FDA 510(k) Applications for Medical Device Product Code "FRG"
(Wrap, Sterilization)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K013003 | ADVANCED STERILIZATION PRODUCTS | APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER | 08/28/2002 |
| K103210 | ADVANCED STERILIZATION PRODUCTS | TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS | 06/06/2011 |
| K141693 | ADVANCED STERILIZATION PRODUCTS | Tyvek« Pouch/Roll with STERRAD« Chemical Indicator | 12/19/2014 |
| K093649 | AESCULAP | AESCULAP STERILCONTAINER S | 05/11/2010 |
| K062510 | AESCULAP | AESCULAP STERILCONTAINER SYSTEM | 11/17/2006 |
| K040865 | AESCULAP | AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER | 12/06/2004 |
| K093493 | AESCULAP, INC. | AESCULAP STERILCONTAINER S | 07/27/2010 |
| K053389 | AESCULAP, INC. | AESCULAP STERILCONTAINER SYSTEM | 02/15/2006 |
| K041623 | AESCULAP, INC. | REUSABLE STERILCONTAINER FILTER MODEL #JK090 | 12/13/2004 |
| K160755 | AHLSTROM NONWOVENS LLC | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | 07/27/2016 |
| K171533 | Ahlstrom Nonwovens LLC | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | 06/29/2017 |
| K230137 | Ahlstrom-Munksjo Nonwovens LLC | Reliance« Fusion Sterilization Wraps | 12/07/2023 |
| K983299 | ALLEGIANCE HEALTHCARE CORP. | ALLEGIANCE GENESIS CONTAINER SYSTEM | 08/04/2000 |
| K983719 | ALLEGIANCE HEALTHCARE CORP. | BIOSHIELD EXPRESS STERILIZATION WRAP | 08/25/1999 |
| K993871 | ALLEGIANCE HEALTHCARE CORP. | BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP | 04/21/2000 |
| K012931 | ALLEGIANCE HEALTHCARE CORP. | GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM | 08/20/2002 |
| K990300 | ALLEGIANCE HEALTHCARE CORP. | SUPRASHIELD EXPRESS STERILIZATION WRAP | 02/10/1999 |
| K143117 | AMERICAN ORTHODONTICS | Wire Sterilization Package with Indicators | 10/29/2015 |
| K971483 | AMERICAN THRESHOLD INDUSTRIES, INC. | SECURE-WRAP (TM) STERILIZATION WRAP | 06/24/1997 |
| K152291 | ANDERSEN STERILIZERS, INC. | Sterisheet Sterilization Wrap | 12/17/2015 |
| K200335 | Andersen Sterilizers, Inc. | Sterisheet Sterilization Wrap | 11/12/2020 |
| K170429 | Andersen Sterilizers, Inc. | Tyvek Sterilization Pouches with Chevron Seal | 10/27/2017 |
| K200336 | Andersen Sterilizers, Inc. | Tyvek Sterilization Pouches with Chevron Seal | 11/12/2020 |
| K170437 | Andersen Sterilizers,Inc. | Sterisheet Sterilization Wrap | 11/01/2017 |
| K152058 | Andersen Sterilizers,Inc. | Tyvek Sterilization Pouches with Chevron Seal | 11/18/2015 |
| K241565 | Anqing Clean Dental Instrument Technology Co., Ltd. | Sterilization Package/Reel | 02/24/2025 |
| K110954 | ARJO WIGGINS MEDICAL, INC. | ARJORAD STERILE WRAP | 08/24/2012 |
| K062100 | ARJO WIGGINS MEDICAL, INC. | ARJOWRAP 47/100 AND 47/88 | 12/05/2006 |
| K042580 | BANTA HEALTHCARE GROUP, LTD. | TIDI BRAND STERILIZATION WRAP | 11/17/2004 |
| K172280 | BH Medical Products Co., Ltd. | BH Sterilization Pouch | 08/03/2018 |
| K983223 | BRASSELER USA I, L.P. | DENTAL STERLIZATION TRAY/CASSETTE | 01/14/1999 |
| K181174 | Cardinal Health 200 LLC | Cardinal Health Sterilization Wrap | 12/11/2018 |
| K151445 | CARDINAL HEALTH 200, LLC | Cardinal Health Sterilization Wrap | 12/21/2015 |
| K151788 | Cardinal Health 200, LLC | Cardinal Health Sterilization Wrap | 10/30/2015 |
| K161910 | CARDINAL HEALTH 200, LLC | Cardinal Health Sterilization Wrap | 04/20/2017 |
| K112211 | CARDINAL HEALTH 200, LLC | DURA BLUE STERILIZATION WRAP | 10/20/2011 |
| K112283 | CARDINAL HEALTH 200, LLC | DURA BLUE STERILIZATION WRAP | 10/20/2011 |
| K112918 | CARDINAL HEALTH 200, LLC | DURABLUE STERILIZATION (AMSCO V-PRO) WRAP | 01/20/2012 |
| K120658 | CARDINAL HEALTH 200, LLC | DURABLUE STERILIZATION WRAP | 06/13/2012 |
| K123857 | CARDINAL HEALTH 200, LLC | DURABLUE STERILIZATION WRAP | 01/23/2013 |
| K130927 | CARDINAL HEALTH 200, LLC | DURABLUE STERILIZATION WRAP | 06/18/2013 |
| K122507 | CARDINAL HEALTH 200, LLC | DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION | 09/26/2012 |
| K120542 | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES | CARDINAL HEALTH DURABLUE STERILIZATION WRAP | 06/01/2012 |
| K123289 | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES | DURABLUE STERILIZATION WRAP | 02/28/2013 |
| K132060 | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES | DURABLUE STERILIZATION WRAP | 12/13/2013 |
| K213907 | Care Essentials Pty Ltd | CareGUARD Sterilization Wrap | 03/14/2022 |
| K972138 | CARR METAL PRODUCTS, INC. | CARR RIGID CONTAINER SYSTEM | 11/13/1997 |
| K023658 | CARR METAL PRODUCTS, INC. | STERILIZATION CASES AND TRAYS | 03/25/2003 |
| K112904 | CASE MEDICAL, INC. | STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS | 01/24/2012 |
| K080558 | CASE MEDICAL, INC. | STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS | 12/05/2008 |
| K022978 | CASE MEDICAL, INC. | STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS | 05/09/2003 |
| K161415 | CASE MEDICAL, INC. | SteriTite Containers System & MediTray Products | 02/10/2017 |
| K030853 | CASE MEDICAL, INC. | STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI | 03/21/2003 |
| K991023 | CASE MEDICAL, INC. | STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL | 01/27/2000 |
| K023614 | CASE MEDICAL, INC. | STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM | 04/07/2003 |
| K974638 | CASE MEDICAL, INC. | STERITITE SEALED CONTAINERS MODEL SCO4Q | 12/18/1997 |
| K090068 | CASE MEDICAL, INC. | STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS | 02/24/2010 |
| K993255 | COLTENE/WHALEDENT INC. | BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE | 12/06/1999 |
| K993835 | COLTENE/WHALEDENT INC. | PARAPOST SYSTEM STERILIZABLE ORGANIZER | 12/16/1999 |
| K240438 | Comercializadora Brever | CDB Hospital « Sterilization Wrap (70 gsm); CDB Hospital « Sterilization Wrap (44 gsm) | 11/04/2024 |
| K052992 | CONMED LINVATEC | CONMED LINVATEC INSTRUMENT STERILIZATION TRAY | 10/16/2006 |
| K955678 | CONTOUR FABRICATORS OF FLORIDA, INC. | RNS STERILE DISPOSABLE PUNCTURE TRAY | 02/21/1996 |
| K955688 | CONTOUR FABRICATORS OF FLORIDA, INC. | RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY | 02/21/1996 |
| K955686 | CONTOUR FABRICATORS OF FLORIDA, INC. | RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY | 02/21/1996 |
| K110867 | CPAC, INC. | STERI-DENT, STERI-SURE | 07/20/2011 |
| K960208 | CUSTOM PACK RELIABILITY | CPR BASIC SET-UP TRAY | 03/28/1996 |
| K960206 | CUSTOM PACK RELIABILITY | CPR DRESSING CHANGE TRAY | 04/12/1996 |
| K960207 | CUSTOM PACK RELIABILITY | CPR LACERATION TRAY | 02/27/1996 |
| K960210 | CUSTOM PACK RELIABILITY | CPR ORTHO HAND PACK | 04/12/1996 |
| K960238 | CUSTOM PACK RELIABILITY | CPR SUTURE REMOVAL KIT | 03/28/1996 |
| K960213 | CUSTOM PACK RELIABILITY | CPR TOTAL HIP PACK | 04/12/1996 |
| K960211 | CUSTOM PACK RELIABILITY | CPR TOTAL KNEE PACK | 04/12/1996 |
| K233262 | Dukal LLC | Dukal SMS Sterilization Wrap | 03/22/2024 |
| K960201 | GE MEDICAL SYSTEMS | G.E. STERILE BREAST BIOPSY/LOCALIZATION TRAY | 02/21/1996 |
| K960202 | GE MEDICAL SYSTEMS | G.E. STERILE PUNCTURE TRAY | 02/21/1996 |
| K960204 | GE MEDICAL SYSTEMS | G.E. STERILE, PERCUTANEOUS CHOLANGIOGRAPHIC TRAY | 02/27/1996 |
| K960141 | GE MEDICAL SYSTEMS | G.E. STERILE, STANDARD BIOPSY TRAY | 02/21/1996 |
| K250321 | George Courey Inc. | GCI Sterilization Wrappers | 06/06/2025 |
| K990567 | GLOBAL HEALTHCARE, INC. | GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH | 04/05/1999 |
| K052665 | GRANTON MEDICAL LTD. | GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES | 02/27/2006 |
| K023025 | GRANTON MEDICAL LTD. | SELF SEAL STERILIZATION POUCH | 03/04/2003 |
| K141412 | GS MEDICAL PACKAGING, INC. | STERILUCENT SELF-SEAL STERILIZATION POUCH | 12/03/2014 |
| K141712 | Halyard Health | KIMGUARD ONE STEP STERILIZATION WRAP | 12/18/2014 |
| K102783 | HINSON AND HALE MEDICAL TECHNOLOGIES, INC | HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS | 12/22/2010 |
| K961227 | J.J. SKINNER, INC. | JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY | 06/10/1996 |
| K182656 | Jiangsu Zhande Medical Supplies Co., Ltd | JAMBRO Single Core A Sterilization wrap | 06/11/2019 |
| K222151 | Kenpax International Limited | Sterilization Wrap | 03/23/2023 |
| K112805 | KIMBERLY-CLARK CORP. | KIMGUARD ONE-STEP STERILIZATION WRAP | 06/22/2012 |
| K082177 | KIMBERLY-CLARK CORP. | KIMGUARD ONE-STEP STERILIZATION WRAP | 03/27/2009 |
| K091685 | KIMBERLY-CLARK CORP. | KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600 | 09/03/2009 |
| K092167 | KIMBERLY-CLARK CORP. | KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600 | 11/02/2009 |
| K140963 | KIMBERLY-CLARK CORP. | KIMGUARD SMART-FOLD STERILIZATION WRAP | 11/10/2014 |
| K112300 | KIMBERLY-CLARK CORP. | KIMGUARD SMART-FOLD* STERILIZATION WRAP | 01/19/2012 |
| K082554 | KIMBERLY-CLARK CORP. | KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600 | 05/01/2009 |
| K113806 | KIMBERLY-CLARK HEALTH CARE | KIMGUARD ONE STEP STERILIZATION WRAP | 08/20/2013 |
| K141071 | KIMBERLY-CLARK HEALTH CARE | KIMGUARD ONE-STEP STERILIZATION WRAP | 07/28/2014 |
| K141612 | KIMBERLY-CLARK HEALTH CARE | KIMGUARD ONE-STEP STERILIZATION WRAP | 08/07/2014 |
| K142782 | Kimberly-Clark Health Care | KIMGUARD ONE-STEP Sterilization Wrap | 03/09/2015 |
| K143053 | KIMBERLY-CLARK HEALTH CARE | KIMGUARD ONE-STEP Sterilization Wrap | 04/03/2015 |
| K241123 | KM Corp. | PerpakÖ Sterilization Tyvek Pouch | 09/18/2024 |
| K102864 | LAC MAC, LTD. | 84E SERIES SINGLE PLY WRAPPER | 01/14/2011 |
| K964256 | MADISON POLYMERIC ENGINEERING | CYGNUS INSTRUMENT PROTECTORS | 05/06/1997 |
| K182184 | MDK (ShangHai) Medical Packing Co., Ltd. | Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) | 10/10/2019 |
| K970152 | MEDCARE MEDICAL GROUP, INC. | BIOPSY TRAY | 03/05/1997 |
| K960520 | MEDCO INSTRUMENTS, INC. | LACERATION TRAY | 03/21/1996 |
| K243431 | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | Medicom Sterilization Pouch and Reel | 02/21/2025 |
| K240862 | Medicom Group, Inc | Medicom Sterilization Wrap | 06/21/2024 |
| K010825 | MEDLINE | MEDLINE STERISET STERILIZATION CONTAINER | 05/08/2001 |
| K152458 | MEDLINE INDUSTRIES, INC. | Gemini Bonded Sterilization Wrap | 06/01/2016 |
| K143147 | MEDLINE INDUSTRIES, INC. | Gemini Bonded Sterilization Wrap | 05/07/2015 |
| K150698 | MEDLINE INDUSTRIES, INC. | Gemini Sterilization Wrap | 11/20/2015 |
| K152564 | MEDLINE INDUSTRIES, INC. | Gemini Sterilization Wrap | 07/07/2016 |
| K162993 | Medline Industries, Inc. | Gemini Sterilization Wrap | 06/23/2017 |
| K113353 | MEDLINE INDUSTRIES, INC. | GEMINI STERILZATION WRAP | 01/31/2013 |
| K192641 | Medline Industries, Inc. | Gemini Titan Sterilization Wrap | 01/24/2020 |
| K002968 | MEDLINE INDUSTRIES, INC. | MEDLINE STERILIZATION WRAP | 01/23/2001 |
| K220365 | Medline Industries, LP | Gemini Sterilization Wrap | 10/06/2022 |
| K234132 | Medline Industries, LP | Medline Reusable Sterilization Wrappers | 09/17/2024 |
| K234050 | O&M Halyard, Inc. | HALYARD« ONE-STEP« Sterilization Wrap, HALYARD« QUICK CHECK« Sterilization Wrap, HALYARD« SEQUENTIAL Sterilization Wrap and HALYARD« SMART-FOLD« Sterilization Wrap | 09/16/2024 |
| K240330 | O&M Halyard, Inc. | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) | 08/07/2024 |
| K192147 | Owens & Minor (O&M) Halyard, Inc | Halyard ONE-STEP* Sterilization Wrap | 10/10/2019 |
| K214007 | Owens & Minor (O&M) Halyard, Inc. | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap | 07/27/2022 |
| K181959 | Owens& Minor Halyard, Inc. | HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) | 03/22/2019 |
| K212198 | Plasmapp Co,.Ltd. | Tyvek(R) Roll with CI for STERLINKTM Sterilizer | 10/22/2021 |
| K223025 | Plasmapp Co., Ltd. | Tyvek Roll with CI for STERLINK Sterilizer | 05/09/2023 |
| K160595 | PMS Medikal Ambalaj Sanayi ve Ticaret LTD STI | PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator | 11/18/2016 |
| K162362 | PMS TIBBI CIHAZLAR TEKNOLOJISI SAN VE TIC AS | PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator | 10/13/2017 |
| K152669 | PMS TIP TEKNOLOJILERI SANAYI VE TICARET LIMITED STD | PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) | 01/15/2016 |
| K233777 | PRIMED Medical Products Inc. | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | 05/24/2024 |
| K242208 | PRIMED Medical Products Inc. | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | 10/07/2024 |
| K221875 | Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. | Sterilization Pouch and Roll | 02/13/2023 |
| K013715 | QUALITY PRODUCTS OF MONTANA | RE-USABLE STERILIZATION POUCH / BAG | 04/01/2002 |
| K993535 | RILEY MEDICAL, INC. | METAPAK MULTI-PURPOSE INSTRUMENT TRAY | 12/07/2001 |
| K031022 | RONPAK, INC. | PROTEC-TOP, STERIDENT, BENTO | 04/14/2003 |
| K153540 | SAFE SECURE PACKAGING CO., LTD | Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators | 08/04/2016 |
| K112591 | SAFE SECURE PACKAGING CO., LTD | SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS | 02/07/2012 |
| K180139 | Safe Secure Packing Co., Ltd. | Safe Secure Sterilization Pouches and Rolls | 01/03/2019 |
| K071886 | SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD. | SELF SEAL STERILIZATION POUCH | 12/27/2007 |
| K242898 | Shanghai Jianzhong Medical Packaging Co., Ltd. | Sterilization Pouches and Reels | 02/21/2025 |
| K242839 | Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd. | Safe Secure Sterilization Pouches and Rolls | 10/16/2024 |
| K102158 | SIGMA MEDICAL SUPPLIES CORP. | SIGMA STERILIZATION POUCH & ROLL | 08/02/2011 |
| K180661 | Sigma Medical Supplies Corp. | SIGMA Sterilization Pouch and Roll | 06/05/2018 |
| K133838 | SIGMA MEDICAL SUPPLIES CORP. | STERILIZATION POUCH/ROLL MADE WITH TYVEK | 03/11/2015 |
| K202462 | Sigma Medical Supplies Corporation | SIGMA Sterilization Pouch and Roll | 04/23/2021 |
| K180672 | Sigma Medical Supplies Corporation | Sterilization Pouch/Roll Made with Tyvek | 06/06/2018 |
| K191131 | Solidence Surgical Corporation | Solidence Multipockets | 08/03/2022 |
| K162162 | Standard Textile Co., Inc. | Barrier Supreme Sterilization Wrapper | 11/04/2016 |
| K172207 | Standard Textile Co., Inc. | Standard Supreme Sterilization Wrapper | 08/25/2017 |
| K212338 | SterileRight Packaging Mfg., Inc. | SterileRight sterilization pouch and roll | 11/01/2021 |
| K222440 | Steris | Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays | 09/09/2022 |
| K071087 | STERIS Corporation | VIS-U-ALL II HEAT-SEAL POUCH AND TUBING | 10/16/2007 |
| K160908 | STERIS CORPORATION | Vis-U-All Low Temperature Sterilization Pouch/Tubing | 07/22/2016 |
| K183297 | STERIS Corporation | Vis-U-All Low Temperature Sterilization Pouch/Tubing | 01/03/2019 |
| K183401 | STERIS Corporation | Vis-U-All Low Temperature Sterilization Pouch/Tubing | 03/01/2019 |
| K140487 | STERIS Corporation | VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING | 07/22/2014 |
| K172749 | Steris Corporation | Vis-U-All Low Temperature Sterilization Pouch/Tubing | 02/09/2018 |
| K231500 | Steris Corporation | Vis-U-All Low Temperature Sterilization Pouches | 08/07/2023 |
| K962605 | SURGICOT, INC. | PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) | 03/11/1997 |
| K113776 | SYMMETRY MEDICAL | FLASHPAK | 08/08/2012 |
| K141826 | SYMMETRY MEDICAL INC- MANCHESTER | FLASHPAK STERILIZATION CONTAINER SYSTEM | 04/02/2015 |
| K181957 | Tianchang Jiarui Packaging Material Co., Ltd. | Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted | 07/09/2019 |
| K162258 | Tianchang Jiarui Packaging Material Co., Ltd. | Self Sealing Sterilization Pouches | 04/28/2017 |
| K955658 | TRANSIDYNE GENERAL CORP. | LACERATION TRAY | 01/25/1996 |
| K080198 | TSO3 INC. | TSO3 OZONE STERILIZATION WRAP | 05/30/2008 |
| K250011 | Turbett Surgical | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) | 04/04/2025 |
| K200240 | Turbett Surgical Inc. | Turbett Instrument Pod | 04/30/2020 |
| K202593 | Turbett Surgical Inc. | Turbett Instrument Pod | 05/19/2021 |
| K153025 | TURBETT SURGICAL LLC | Turbett Surgical Container | 01/14/2016 |
| K990761 | TUTTNAUER USA CO. LTD. | TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE | 07/09/1999 |
| K123162 | U&U MEDICAL TECHNOLOGY CO., LTD | U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL | 02/26/2014 |
| K143637 | U&U Medical Technology Co.,Ltd | U&U Sterilization Pouch and Roll | 09/09/2015 |
| K040707 | VYGON US LLC | PACKAGING TRAY AND COMPONENTS | 04/16/2004 |
| K041096 | WAGNER GMBH | WAGNER STERISET STERILIZATION CONTAINER | 06/03/2005 |
| K220133 | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | Sterilization Wraps | 03/10/2022 |
| K193561 | Weihai Xingtai Packaging Products Co.,Ltd. | Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch | 04/15/2020 |
| K183356 | Weihai Xingtai Packaging Products Co.,Ltd. | Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch | 08/19/2019 |
| K243721 | Wellmed Dental Medical Supply Co., Ltd | Self Sealing Sterilization Pouches | 04/25/2025 |
| K062704 | WINNER INDUSTRIES (SHENZHEN) CO., LTD. | STERILIZATION POUCH WITH INDICATORS | 06/08/2007 |
| K210810 | Wipak OY | Steiking Packaging for Medical Devices | 01/23/2022 |
| K221377 | Wipak OY | SteriKing LT-Blueline Pouches with Tyvek | 12/22/2022 |
| K221379 | Wipak OY | Steriking LT-Blueline Pouches with Tyvek | 01/04/2023 |
| K221016 | Wipak OY | Steriking Packaging for Medical Devices | 05/05/2022 |
| K231996 | Wipak OY | Steriking« LT-Blueline Pouches with Tyvek« | 09/07/2023 |
| K231999 | Wipak OY | Steriking« LT-Blueline Pouches with Tyvek« | 09/07/2023 |
| K232625 | Wipak OY | Steriking« Pouch for Robotic Instruments | 06/07/2024 |
| K223600 | Wuhan Zonsen Medical Products Co., Ltd. | Sterilization Wrap | 08/25/2023 |
| K243179 | Yichang Xinxin Paper Products Co., Ltd. | Sterilization Pouch and Roll | 06/26/2025 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
