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) (7) Indicator, Physical/Chemical Sterilization Process (JOJ) (3)

Premarket Exempt

Clear

Tuttnauer® - 07798164677888 Catalog Number :

Device Description : Moving front chemical integrator for steam sterilization processes.

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 250

Stryker - 07798164678175 Catalog Number :

Device Description : Sterizone LCD Incubator for biological indicators

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

Stryker - 07798164678182 Catalog Number :

Device Description : Sterizone Basic Incubator for biological indicators

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

Stryker - 07798164678205 Catalog Number :

Device Description : Sterizone Sealing Tape

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

Stryker - 07798164678212 Catalog Number :

Device Description : Sterizone CI – Low Temp

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 250

Bionova® - 07798164678410 Catalog Number :

Device Description : Steam Test Pack PCD Kit (25 test packs and 5 control BIs)

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

Bionova® - 07798164678427 Catalog Number :

Device Description : Steam Test Pack PCD Kit (16 test packs and 4 control Bis)

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

Bionova® - 07798164678434 Catalog Number :

Device Description : Steam Test Pack PCD Kit (25 test packs and 5 control BIs)

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

Bionova® - 07798164678441 Catalog Number :

Device Description : Steam Test Pack PCD Kit (16 test packs and 4 control Bis)

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

Bionova® - 07798164678458 Catalog Number :

Device Description : Steam Test Pack PCD Kit (25 test packs and 5 control BIs)

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

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