FDA Product Code
FDA Product Code FRG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6850
510(k) Clearances — 323 records · page 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K141071 | KIMGUARD ONE-STEP STERILIZATION WRAP | Kimberly-Clark Health Care | 2014-07-28 | Traditional | PDF ↗ |
| K140487 | VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING | STERIS Corporation | 2014-07-22 | Traditional | PDF ↗ |
| K123162 | U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL | U&U Medical Technology Co, Ltd. | 2014-02-26 | Traditional | PDF ↗ |
| K132060 | DURABLUE STERILIZATION WRAP | Cardinal Health-Medical Products and Services | 2013-12-13 | Traditional | PDF ↗ |
| K113806 | KIMGUARD ONE STEP STERILIZATION WRAP | Kimberly-Clark Health Care | 2013-08-20 | Traditional | PDF ↗ |
| K130927 | DURABLUE STERILIZATION WRAP | Cardinal Health200, LLC | 2013-06-18 | Special | PDF ↗ |
| K123289 | DURABLUE STERILIZATION WRAP | Cardinal Health-Medical Products and Services | 2013-02-28 | Traditional | PDF ↗ |
| K113353 | GEMINI STERILZATION WRAP | Medline Industries, Inc. | 2013-01-31 | Traditional | PDF ↗ |
| K123857 | DURABLUE STERILIZATION WRAP | Cardinal Health200, LLC | 2013-01-23 | Traditional | PDF ↗ |
| K122507 | DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION | Cardinal Health200, LLC | 2012-09-26 | Traditional | PDF ↗ |
| K110954 | ARJORAD STERILE WRAP | Arjo Wiggins Medical, Inc. | 2012-08-24 | Traditional | PDF ↗ |
| K113776 | FLASHPAK | Symmetry Medical | 2012-08-08 | Traditional | PDF ↗ |
| K112805 | KIMGUARD ONE-STEP STERILIZATION WRAP | Kimberly-Clark Corp. | 2012-06-22 | Traditional | PDF ↗ |
| K120658 | DURABLUE STERILIZATION WRAP | Cardinal Health200, LLC | 2012-06-13 | Traditional | PDF ↗ |
| K120542 | CARDINAL HEALTH DURABLUE STERILIZATION WRAP | Cardinal Health-Medical Products and Services | 2012-06-01 | Traditional | PDF ↗ |
| K112591 | SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS | Safe Secure Packaging Co., Ltd. | 2012-02-07 | Traditional | PDF ↗ |
| K112904 | STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS | Case Medical, Inc. | 2012-01-24 | Traditional | PDF ↗ |
| K112918 | DURABLUE STERILIZATION (AMSCO V-PRO) WRAP | Cardinal Health200, LLC | 2012-01-20 | Traditional | PDF ↗ |
| K112300 | KIMGUARD SMART-FOLD* STERILIZATION WRAP | Kimberly-Clark Corp. | 2012-01-19 | Special | PDF ↗ |
| K112283 | DURA BLUE STERILIZATION WRAP | Cardinal Health200, LLC | 2011-10-20 | Traditional | PDF ↗ |
| K112211 | DURA BLUE STERILIZATION WRAP | Cardinal Health200, LLC | 2011-10-20 | Traditional | PDF ↗ |
| K102158 | SIGMA STERILIZATION POUCH & ROLL | Sigma Medical Supplies Corp. | 2011-08-02 | Traditional | PDF ↗ |
| K110867 | STERI-DENT, STERI-SURE | Cpac, Inc. | 2011-07-20 | Traditional | PDF ↗ |
| K103210 | TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS | Advanced Sterilization Products | 2011-06-06 | Traditional | PDF ↗ |
| K102864 | 84E SERIES SINGLE PLY WRAPPER | Lac Mac, Ltd. | 2011-01-14 | Traditional | PDF ↗ |
| K102783 | HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS | Hinson and Hale Medical Technologies, Inc. | 2010-12-22 | Traditional | PDF ↗ |
| K093493 | AESCULAP STERILCONTAINER S | Aesculap, Inc. | 2010-07-27 | Traditional | PDF ↗ |
| K093649 | AESCULAP STERILCONTAINER S | Aesculap | 2010-05-11 | Traditional | PDF ↗ |
| K090068 | STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS | Case Medical, Inc. | 2010-02-24 | Traditional | PDF ↗ |
| K092167 | KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600 | Kimberly-Clark Corp. | 2009-11-02 | Traditional | PDF ↗ |
| K091685 | KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600 | Kimberly-Clark Corp. | 2009-09-03 | Traditional | PDF ↗ |
| K082554 | KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600 | Kimberly-Clark Corp. | 2009-05-01 | Traditional | PDF ↗ |
| K082177 | KIMGUARD ONE-STEP STERILIZATION WRAP | Kimberly-Clark Corp. | 2009-03-27 | Traditional | PDF ↗ |
| K080558 | STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS | Case Medical, Inc. | 2008-12-05 | Traditional | PDF ↗ |
| K080198 | TSO3 OZONE STERILIZATION WRAP | Tso3, Inc. | 2008-05-30 | Traditional | PDF ↗ |
| K071886 | SELF SEAL STERILIZATION POUCH | Shanghai Jianzhong Medical Packaging Co., Ltd. | 2007-12-27 | Traditional | PDF ↗ |
| K071087 | VIS-U-ALL II HEAT-SEAL POUCH AND TUBING | STERIS Corporation | 2007-10-16 | Traditional | PDF ↗ |
| K062704 | STERILIZATION POUCH WITH INDICATORS | Winner Industries (Shenzhen) Co., Ltd. | 2007-06-08 | Traditional | PDF ↗ |
| K062100 | ARJOWRAP 47/100 AND 47/88 | Arjo Wiggins Medical, Inc. | 2006-12-05 | Special | PDF ↗ |
| K062510 | AESCULAP STERILCONTAINER SYSTEM | Aesculap | 2006-11-17 | Traditional | PDF ↗ |
| K052992 | CONMED LINVATEC INSTRUMENT STERILIZATION TRAY | Conmed Linvatec | 2006-10-16 | Traditional | PDF ↗ |
| K052665 | GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES | Granton Medical , Ltd. | 2006-02-27 | Traditional | PDF ↗ |
| K053389 | AESCULAP STERILCONTAINER SYSTEM | Aesculap, Inc. | 2006-02-15 | Traditional | PDF ↗ |
| K041096 | WAGNER STERISET STERILIZATION CONTAINER | Wagner GmbH | 2005-06-03 | Traditional | PDF ↗ |
| K041623 | REUSABLE STERILCONTAINER FILTER MODEL #JK090 | Aesculap, Inc. | 2004-12-13 | Traditional | PDF ↗ |
| K040865 | AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER | Aesculap | 2004-12-06 | Traditional | PDF ↗ |
| K042580 | TIDI BRAND STERILIZATION WRAP | Banta Healthcare Group, Ltd. | 2004-11-17 | Traditional | PDF ↗ |
| K040707 | PACKAGING TRAY AND COMPONENTS | Vygon Us, LLC | 2004-04-16 | Special | PDF ↗ |
| K022978 | STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS | Case Medical, Inc. | 2003-05-09 | Traditional | PDF ↗ |
| K031022 | PROTEC-TOP, STERIDENT, BENTO | Ronpak, Inc. | 2003-04-14 | Special | PDF ↗ |
| K023614 | STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM | Case Medical, Inc. | 2003-04-07 | Traditional | PDF ↗ |
| K023658 | STERILIZATION CASES AND TRAYS | Carr Metal Products, Inc. | 2003-03-25 | Traditional | PDF ↗ |
| K030853 | STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI | Case Medical, Inc. | 2003-03-21 | Traditional | PDF ↗ |
| K023025 | SELF SEAL STERILIZATION POUCH | Granton Medical , Ltd. | 2003-03-04 | Traditional | PDF ↗ |
| K013003 | APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER | Advanced Sterilization Products | 2002-08-28 | Traditional | PDF ↗ |
| K012931 | GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM | Allegiance Healthcare Corp. | 2002-08-20 | Traditional | PDF ↗ |
| K013715 | RE-USABLE STERILIZATION POUCH / BAG | Quality Products of Montana | 2002-04-01 | Traditional | PDF ↗ |
| K993535 | METAPAK MULTI-PURPOSE INSTRUMENT TRAY | Riley Medical, Inc. | 2001-12-07 | Traditional | PDF ↗ |
| K010825 | MEDLINE STERISET STERILIZATION CONTAINER | Medline | 2001-05-08 | Traditional | PDF ↗ |
| K002968 | MEDLINE STERILIZATION WRAP | Medline Industries, Inc. | 2001-01-23 | Traditional | PDF ↗ |
| K983299 | ALLEGIANCE GENESIS CONTAINER SYSTEM | Allegiance Healthcare Corp. | 2000-08-04 | Traditional | PDF ↗ |
| K993871 | BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP | Allegiance Healthcare Corp. | 2000-04-21 | Traditional | PDF ↗ |
| K991023 | STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL | Case Medical, Inc. | 2000-01-27 | Traditional | PDF ↗ |
| K993835 | PARAPOST SYSTEM STERILIZABLE ORGANIZER | Coltene/Whaledent, Inc. | 1999-12-16 | Traditional | PDF ↗ |
| K993255 | BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE | Coltene/Whaledent, Inc. | 1999-12-06 | Traditional | PDF ↗ |
| K983719 | BIOSHIELD EXPRESS STERILIZATION WRAP | Allegiance Healthcare Corp. | 1999-08-25 | Traditional | PDF ↗ |
| K990761 | TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE | Tuttnauer U.S.A Co, Ltd. | 1999-07-09 | Traditional | PDF ↗ |
| K990567 | GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH | Global Healthcare, Inc. | 1999-04-05 | Traditional | PDF ↗ |
| K990300 | SUPRASHIELD EXPRESS STERILIZATION WRAP | Allegiance Healthcare Corp. | 1999-02-10 | Special | PDF ↗ |
| K983223 | DENTAL STERLIZATION TRAY/CASSETTE | Brasseler USA I, L.P. | 1999-01-14 | Traditional | PDF ↗ |
| K974638 | STERITITE SEALED CONTAINERS MODEL SCO4Q | Case Medical, Inc. | 1997-12-18 | Traditional | PDF ↗ |
| K972138 | CARR RIGID CONTAINER SYSTEM | Carr Metal Products, Inc. | 1997-11-13 | Traditional | PDF ↗ |
| K971483 | SECURE-WRAP (TM) STERILIZATION WRAP | American Threshold Industries, Inc. | 1997-06-24 | Traditional | PDF ↗ |
| K964256 | CYGNUS INSTRUMENT PROTECTORS | Madison Polymeric Engineering | 1997-05-06 | Traditional | PDF ↗ |
| K962605 | PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) | Surgicot, Inc. | 1997-03-11 | Traditional | PDF ↗ |
| K970152 | BIOPSY TRAY | Medcare Medical Group, Inc. | 1997-03-05 | Traditional | PDF ↗ |
| K961227 | JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY | J.J. Skinner, Inc. | 1996-06-10 | Traditional | PDF ↗ |
| K960210 | CPR ORTHO HAND PACK | Custom Pack Reliability | 1996-04-12 | Traditional | PDF ↗ |
| K960211 | CPR TOTAL KNEE PACK | Custom Pack Reliability | 1996-04-12 | Traditional | PDF ↗ |
| K960206 | CPR DRESSING CHANGE TRAY | Custom Pack Reliability | 1996-04-12 | Traditional | PDF ↗ |
| K960213 | CPR TOTAL HIP PACK | Custom Pack Reliability | 1996-04-12 | Traditional | PDF ↗ |
| K960238 | CPR SUTURE REMOVAL KIT | Custom Pack Reliability | 1996-03-28 | Traditional | PDF ↗ |
| K960208 | CPR BASIC SET-UP TRAY | Custom Pack Reliability | 1996-03-28 | Traditional | PDF ↗ |
| K960520 | LACERATION TRAY | Medco Instruments, Inc. | 1996-03-21 | Traditional | PDF ↗ |
| K960207 | CPR LACERATION TRAY | Custom Pack Reliability | 1996-02-27 | Traditional | PDF ↗ |
| K960204 | G.E. STERILE, PERCUTANEOUS CHOLANGIOGRAPHIC TRAY | GE Medical Systems | 1996-02-27 | Traditional | PDF ↗ |
| K955678 | RNS STERILE DISPOSABLE PUNCTURE TRAY | Contour Fabricators of Florida, Inc. | 1996-02-21 | Traditional | PDF ↗ |
| K960202 | G.E. STERILE PUNCTURE TRAY | GE Medical Systems | 1996-02-21 | Traditional | PDF ↗ |
| K955686 | RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY | Contour Fabricators of Florida, Inc. | 1996-02-21 | Traditional | PDF ↗ |
| K960201 | G.E. STERILE BREAST BIOPSY/LOCALIZATION TRAY | GE Medical Systems | 1996-02-21 | Traditional | PDF ↗ |
| K960141 | G.E. STERILE, STANDARD BIOPSY TRAY | GE Medical Systems | 1996-02-21 | Traditional | PDF ↗ |
| K955688 | RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY | Contour Fabricators of Florida, Inc. | 1996-02-21 | Traditional | PDF ↗ |
| K955658 | LACERATION TRAY | Transidyne General Corp. | 1996-01-25 | Traditional | PDF ↗ |
| K953678 | STERIMED STERIZATION WRAPPER (NON-STERILE) | Customed, Inc. | 1995-10-02 | Traditional | PDF ↗ |
| K951704 | NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATION | Products For Medicine | 1995-06-28 | Traditional | PDF ↗ |
| K946019 | SURGICLA INSTRUMENT KIT | Medical Action Industries, Inc. | 1995-03-20 | Traditional | PDF ↗ |
| K950438 | SAFEDWEEL DRESSING CHANGE TRAY | Becton Dickinson Vascular Access, Inc. | 1995-03-15 | Traditional | PDF ↗ |
| K950850 | GENT-L-KARE LACERATION TRAYS | Premium Plastics, Inc. | 1995-03-14 | Traditional | PDF ↗ |
| K943653 | MAMMOCORE BIOPSY TRAY | Manan Medical Products, Inc. | 1995-01-30 | Traditional | PDF ↗ |
| K944881 | SKIN SCRUB TRAY | Clinical Resources, Inc. | 1994-12-27 | Traditional | PDF ↗ |
Product code FRG · Class II · General Hospital. Data: openFDA.