TERRAGENE S.A.

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, Physical/Chemical Sterilization Process (JOJ) (8) Indicator, Biological Sterilization Process (FRC) (2)

Premarket Exempt

No

Clear

Bionova® - 07798164670247 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

Integron® - 07798164671176 Catalog Number :

Device Description : Unique point Integrator Indicator for Steam sterilization processes.

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 200

Chemdye® - 07798164672135 Catalog Number :

Device Description : Chemical indicator strip for monitoring hydrogen peroxide sterilization processes.

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 500

Chemdye® - 07798164672142 Catalog Number :

Device Description : Chemical indicator strip for monitoring hydrogen peroxide sterilization processes.

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 250

Chemdye® - 07798164672173 Catalog Number :

Device Description : Chemical Indicator strip for monitoring hydrogen peroxide sterilization processes.

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 500

Integron® - 07798164672319 Catalog Number :

Device Description : Chemical Integrator For Ethylene Oxide sterilization processes.

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 250

Chemdye® - 07798164672890 Catalog Number :

Device Description : Chemical Indicator strip for monitoring hydrogen peroxide sterilization processes.

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 250

Bionova® - 07798164673651 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

Chemdye® - 07798164673705 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

Cintape® - 07798164673880 Catalog Number :

Device Description : Chemical Indicator tape for monitoring hydrogen peroxide sterilization processes.

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

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