CROSSTEX INTERNATIONAL, INC.

Address:14059 STAGE RD.,Santa Fe Spgs,CA,90670,US

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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) (10)

Premarket Exempt

No Yes

Clear

SporAmpule™ Biological Indicator - 10732224720095 Catalog Number :

Device Description : SporAmpule™ Steam Biological Indicator

Device Class : 2

Duns Number: 057728685

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 20

SporAmpule™ Biological Indicator - 10732224720101 Catalog Number :

Device Description : SporAmpule™ Steam Biological Indicator

Device Class : 2

Duns Number: 057728685

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 100

Dual Species BI Strip - 10732224720156 Catalog Number :

Device Description : Dual Spore Strip,Geobacillus stearothermophilus and Bacillus atrophaeus

Device Class : 2

Duns Number: 057728685

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1000

SporAmpule™ Biological Indicator - 10732224720262 Catalog Number :

Device Description : SporAmpule™ Starter Kit.

Device Class : 2

Duns Number: 057728685

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

SporAmpule™ Biological Indicator - 10732224720774 Catalog Number :

Device Description : SporAmpule™ Steam Biological Indicator

Device Class : 2

Duns Number: 057728685

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 100

SporView™ VH2O2 Self-Contained Hydrogen Peroxide Biological Indicator - 10732224721504 Catalog Number :

Device Description : Self-Contained BI for use in monitoring VH2O2 sterilization processes

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 50

SporView® Self-contained Biological Indicator - 10732224721528 Catalog Number :

Device Description : SCBI 10^6 STEAM, 25/BX

Device Class : 2

Duns Number: 057728685

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 25

ConFirm® Modified Tryptic Soy Broth - 10732224721597 Catalog Number :

Device Description : Modified Tryptic Soy Broth 100/BX

Device Class : 2

Duns Number: 057728685

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 100

Culture Media, 300/BX - 10732224723188 Catalog Number :

Device Description : Culture Media, 300/BX

Device Class : 2

Duns Number: 057728685

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 300

SporView™ 10 Self-Contained Biological Indicator - 10732224723287 Catalog Number :

Device Description : 10 Hour Steam Self-contained Biological Indicator

Device Class : 2

Duns Number: 057728685

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 50

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