TERRAGENE S.A.

Address:Ruta Nacional No. 9, Km 280,,Alvear Santa Fe,AR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Indicator, Biological Sterilization Process (FRC) (6) Indicator, Physical/Chemical Sterilization Process (JOJ) (4)

Premarket Exempt

Clear

Integron® - 07798164676034 Catalog Number :

Device Description : Test pack for Steam sterilization processes.

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

Chemdye® - 07798164676287 Catalog Number :

Device Description : Multivariable process indicator for monitoring Ethylene Oxide sterilization processes

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 250

Bionova® - 07798164676706 Catalog Number :

Device Description : Auto-Reader Incubator for biological indicators

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

Tuttnauer® - 07798164677352 Catalog Number :

Device Description : Super Adherent Indicator Tape For Steam sterilization processes.

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

Tuttnauer® - 07798164677376 Catalog Number :

Device Description : Steam Test Pack PCD Kit (25 test packs and 25 control BIs)

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

Tuttnauer® - 07798164677390 Catalog Number :

Device Description : Steam Test Pack PCD Kit (25 test packs and 25 control BIs)

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

Tuttnauer® - 07798164677406 Catalog Number :

Device Description : Multivariable process indicator for monitoring Steam sterilization processes

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 250

Tuttnauer® - 07798164677437 Catalog Number :

Device Description : Self-contained Biological Indicator for monitoring steam sterilization processes

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 50

Tuttnauer® - 07798164677444 Catalog Number :

Device Description : Self-contained Biological Indicator for monitoring steam sterilization processes

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 50

Tuttnauer® - 07798164677468 Catalog Number :

Device Description : Auto-Reader Incubator for biological indicators

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

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