FRC

Product Code: FRC


Products Classified as FRC

2595Indicator, Biological Sterilization ProcessSterilization Process Indicator.

Total Product Life Cycle (TPLC) Devices

2595Indicator, Biological Sterilization ProcessSterilization Process Indicator.

FDA Consensus Standards

Indicator, Biological Sterilization Process [38444]21 CFR §880.2800 🔎
Indicator, Biological Sterilization Process [38445]21 CFR §880.2800 🔎

Pre-market Notifications for FRC

K220473CELERITY 20 HP Challenge PackSTERIS
K213881Celerity IncubatorSTERIS Corporation
K2138093M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader3M Company
K212193Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)Plasmapp Co., Ltd.
K2102773M Attest Rapid Readout Biological Indicator, 12953M Company
K203560STERIZONE VP4 Test PackTSO3 Inc., Now A Part Of Stryker
K202879EOGas 4 Endo-SteriTest RRBIAndersen Sterilizers, Inc.
K202721Celerity 20 Steam Biological Indicator For IUSSSTERIS Corporation
K2009963M Attest Rapid Readout Biological Indicator3M Company
K2007663M Attest Steam Chemical Integrator Test Pack3M Company
K2005363MTM AttestTM Rapid 5 Steam-Plus Test Pack3M Complany
K200126VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation
K2000923MTM AttestTM Mini Auto-reader 490M3M
K1931543M Attest Super Rapid 5 Steam-Plus Challenge Pack3M Company
K1925503MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 And 490H3M Company

Global Unique Device Identification Database

00366975003416Indicator, Biological Sterilization Process
10304040022419Indicator, biological sterilization process
10304040005184Indicator, biological sterilization process
10304040005177Indicator, biological sterilization process
10304040005160Indicator, biological sterilization process
10304040005153Indicator, biological sterilization process
10304040005146Indicator, biological sterilization process
00304040005132Indicator, biological sterilization process
00690455440201Indicator, Biological Sterilization Process
00690455426021Indicator, Biological Sterilization Process
00724995154257Indicator, biological sterilization process
00724995090036Indicator, biological sterilization process
00724995023904Indicator, biological sterilization process
00707387125394Indicator, biological sterilization process
20814434020794Indicator, Biological Sterilization Process

Maude Adverse Events

CYCLESURE? 24 BIO INDICATORADVANCED STERILIZATION PRODUCTS2020-03-30
CYCLESURE BIO INDICATORADVANCED STERILIZATION PRODUCTS2020-03-17
CYCLESURE? 24 BIO INDICATORADVANCED STERILIZATION PRODUCTS2020-03-11
VELOCITY? 30 BIOLOGICAL INDICATORADVANCED STERILIZATION PRODUCTS2020-02-21
CROSSTEX SPS MEDICAL SPORVIEW CULTURE SETSPS MEDICAL SUPPLY CORP. A DIVISION OF CROSSTEX2020-01-08
CROSSTEX SPS MEDICAL SPORVIEW CULTURE SETSPS MEDICAL SUPPLY CORP. A DIVISION OF CROSSTEX2020-01-08
CROSSTEX SPS MEDICAL SPORVIEW CULTURE SETSPS MEDICAL SUPPLY CORP. A DIVISION OF CROSSTEX2020-01-08
CROSSTEX SPS MEDICAL SPORVIEW CULTURE SETSPS MEDICAL SUPPLY CORP. A DIVISION OF CROSSTEX2020-01-08
CROSSTEX SPS MEDICAL SPORVIEW CULTURE SETSPS MEDICAL SUPPLY CORP. A DIVISION OF CROSSTEX2020-01-08
CYCLESURE? BIO INDICATORADVANCED STERILIZATION PRODUCTS2020-01-02
CYCLESURE? BIO INDICATORADVANCED STERILIZATION PRODUCTS2020-01-02
CYCLESURE? BIO INDICATORADVANCED STERILIZATION PRODUCTS2019-12-02
CYCLESURE? BIO INDICATORADVANCED STERILIZATION PRODUCTS2019-11-22
CYCLESURE? BIO INDICATORADVANCED STERILIZATION PRODUCTS2019-11-22
CYCLESURE? BIO INDICATORADVANCED STERILIZATION PRODUCTS2019-11-04
CYCLESURE? BIO INDICATORADVANCED STERILIZATION PRODUCTS2019-11-04
CYCLESURE? BIO INDICATORADVANCED STERILIZATION PRODUCTS2019-10-21
CYCLESURE? BIO INDICATORADVANCED STERILIZATION PRODUCTS2019-10-16
CYCLESURE? 24 BIO INDICATORADVANCED STERILIZATION PRODUCTS2019-10-16
STERRAD VELOCITY? BIADVANCED STERILIZATION PRODUCTS2019-09-30
STERRAD VELOCITY? BIADVANCED STERILIZATION PRODUCTS2019-08-27
CYCLESURE? 24 BIO INDICATORADVANCED STERILIZATION PRODUCTS2019-08-21
SEALSURE CI TAPE CASEADVANCED STERILIZATION PRODUCTS2019-07-29
STERRAD? VELOCITY? BIADVANCED STERILIZATION PRODUCTS2019-07-23
CYCLESURE? 24 BIOLOGICAL INDICATORADVANCED STERILIZATION PRODUCTS2019-06-14
HU-FRIEDLY SPORECHECK IN-OFFICE SPORE TESTCROSSTEX SPS MEDICAL2019-06-10
CYCLESURE? BIO INDICATORADVANCED STERILIZATION PRODUCTS2019-05-29
CYCLESURE? 24 BIO INDICATORADVANCED STERILIZATION PRODUCTS2019-05-21
CYCLESURE? BIO INDICATORADVANCED STERILIZATION PRODUCTS2019-05-08
CYCLESURE? BIO INDICATORADVANCED STERILIZATION PRODUCTS2019-04-30
CYCLESURE? 24 BIO INDICATORADVANCED STERILIZATION PRODUCTS2019-04-22
CYCLESURE? BIO INDICATORADVANCED STERILIZATION PRODUCTS2019-04-18
STERRAD? SEALSURE CI TAPEADVANCED STERILIZATION PRODUCTS2019-03-29
STERRAD? SEALSURE CI TAPEADVANCED STERILIZATION PRODUCTS2019-03-29
HU-FRIEDLY SPORECHECK IN-OFFICE SPORE TESTCROSSTEX SPS MEDICAL2019-03-20
CYCLESURE? 24 BIO INDICATORADVANCED STERILIZATION PRODUCTS2019-02-25
STERRAD? CHEMICAL INDICATOR STRIPADVANCED STERILIZATION PRODUCTS2019-02-01
CYCLESURE? 24 BIO INDICATORADVANCED STERILIZATION PRODUCTS2019-01-08
CYCLESURE? 24 BIO INDICATORADVANCED STERILIZATION PRODUCTS2019-01-07
CYCLESURE? 24 BIO INDICATORADVANCED STERILIZATION PRODUCTS2018-11-14
CYCLESURE? BIO INDICATORADVANCED STERILIZATION PRODUCTS2018-11-08
MCKESSON BRANDED SCBISPS MEDICAL2018-09-14
CYCLESURE? 24 BIO INDICATORADVANCED STERILIZATION PRODUCTS2018-09-13
CYCLESURE? 24 BIO INDICATORADVANCED STERILIZATION PRODUCTS2018-09-13
STERRAD? VELOCITY? BIADVANCED STERILIZATION PRODUCTS2018-09-12
STERRAD? VELOCITY? BIADVANCED STERILIZATION PRODUCTS2018-09-12
CYCLESURE? 24 BIO INDICATORADVANCED STERILIZATION PRODUCTS2018-07-31
CYCLESURE? 24 BIO INDICATORADVANCED STERILIZATION PRODUCTS2018-07-31
CYCLESURE? 24 BIO INDICATORADVANCED STERILIZATION PRODUCTS2018-07-18
STERRAD VELOCITY? BIADVANCED STERILIZATION PRODUCTS2018-06-14
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