FDA Product Code JOJ: Indicator, Physical/chemical Sterilization Process
FDA product code JOJ covers physical and chemical sterilization process indicators.
These indicators use temperature-sensitive inks, chemical reactions, or physical changes to confirm that instruments have been exposed to sterilization conditions. They provide a visual, immediate confirmation that packages have passed through the sterilization cycle, distinguishing processed from unprocessed items.
JOJ devices are Class II medical devices, regulated under 21 CFR 880.2800 and reviewed by the FDA General Hospital panel.
Leading manufacturers include STERIS Corporation, 3M Company and Spsmedical Supply Corp..
265
Total
264
Cleared
152d
Avg days
1976
Since
265 devices
Cleared
Jan 09, 1998
GLUTATECT
Alden Scientific, Inc.
General Hospital
233d
Cleared
Aug 29, 1997
SPOROX TEST STRIPS
Serim Research Corp.
General Hospital
88d
Cleared
Jun 24, 1997
BROWNE STEAM INDICATOR
Board of Directors, Albert Browne , Ltd.
General Hospital
104d
Cleared
May 08, 1997
STERITEC INTEGRAPH MODEL CI-101
Steritec Products Mfg Co, Inc.
General Hospital
462d
Cleared
Apr 02, 1997
STERITEC DRY HEAT INDICATOR LABEL
Steritec Products Mfg Co, Inc.
General Hospital
637d
Cleared
Apr 01, 1997
ONCE-A-DAY BOWIE AND DICK TEST PACK.
Propper Mfg. Co., Inc.
General Hospital
375d
Cleared
Aug 05, 1996
CROSS-CHECKS EO GAS STERILIZATION MONITOR
Steritec Products Mfg Co, Inc.
General Hospital
451d
Cleared
Apr 04, 1996
PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR
Cottrell, Ltd.
General Hospital
84d
Cleared
Mar 12, 1996
STERITEC CROSS-CHECKS
Steritec Products Mfg Co, Inc.
General Hospital
105d
Cleared
Feb 22, 1996
ATI ETHYLENE OXIDE STERILIZATION INDICATOR
Pymah Corp.
General Hospital
239d
Cleared
Jul 06, 1995
ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION
Pymah Corp.
General Hospital
45d
Cleared
May 10, 1995
ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION
Pymah Corp.
General Hospital
63d
Cleared
Apr 18, 1995
STERIGAGE EO 100%
Pymah Corp.
General Hospital
553d
Cleared
Dec 29, 1994
STERRAD CHEMICAL INDICATOR TAPE
Advanced Sterilization Products
General Hospital
66d
Cleared
Mar 04, 1994
3M AUTOCLAVE TAPES
3M Company
General Hospital
305d
Cleared
Feb 07, 1994
ENDPOINT 500 PERACETIC ACID TEST INDICATORS
Minntech Corp.
General Hospital
294d
Cleared
Nov 17, 1993
GLUTARALDEHYDE MONITORS
Pymah Corp.
General Hospital
427d
Cleared
Oct 04, 1993
STERRAD CHEMICAL INDICATOR
Johnson & Johnson Medical, Inc.
General Hospital
529d
Cleared
Sep 29, 1993
CHEMDI-VHP CHEMICAL INDICATOR
American Sterilizer Co.
General Hospital
499d
Cleared
May 01, 1991
SERIM PERACETIC ACID REAGENT STRIPS
Serim Research Corp.
General Hospital
97d
Cleared
Aug 22, 1990
STEAMLINE
Propper Mfg. Co., Inc.
General Hospital
316d
Cleared
Feb 15, 1990
BOWIE-DICK TEST CARD CATALOG NUMBER 008018
Edward Weck, Inc.
General Hospital
58d
Cleared
Nov 29, 1989
TOWER SELF SEAL STERILIZATION POUCH
Baxter Healthcare Corp
General Hospital
89d
Cleared
Aug 07, 1989
SEALING TAPE, STERILIZATION INDICATOR
Spsmedical Supply Corp.
General Hospital
174d