STERITEC PRODUCT MFG. CO., INC.

Address:74 INVERNESS DR E,Englewood,CO,80112,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, Physical/Chemical Sterilization Process (JOJ) (8) Indicator, Biological Sterilization Process (FRC) (2)

Premarket Exempt

Clear

SteriTec Cross-Checks D - 00814434020004 Catalog Number : CI 105

Device Class : 2

Duns Number: 622223196

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

SteriTec Steri-Pak LF Bowie-Dick Test Pack - 00814434020011 Catalog Number : BD 111

Device Class : 2

Duns Number: 622223196

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

SteriTec Green Card Bowie-Dick Test - 00814434020028 Catalog Number : BD 115, BD 115/120

Device Description : BD 115 = 960 TestsBD 115/120 = 120 Tests

Device Class :

Duns Number: 622223196

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

SteriTec EO Gas Biological Test Pack with Instant Readout Indicator - 00814434020035 Catalog Number : BI 102

Device Description : EO Gas Biological Test Pack with Instant Readout Indicator with 5 controls

Device Class : 2

Duns Number: 622223196

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

SteriTec Biological Test Pack with Instant Readout Integrator - 00814434020042 Catalog Number : BI 103

Device Description : Biological Test Pack with Instant Readout Integrator with 5 controls

Device Class : 2

Duns Number: 622223196

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

SteriTec Smart-Read Biological Test Pack with Instant Readout Integrator - 00814434020059 Catalog Number : BI 108, BI 108/30

Device Description : BI 108 = 30 tests + 5 controlsBI 108/30 = 30 tests + 30 controls

Device Class :

Duns Number: 622223196

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

SteriTec Integraph - 00814434020066 Catalog Number : CI 101, CI 101/BR, CI 101/ITL

Device Class :

Duns Number: 622223196

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

SteriTec Cross-Checks EO - 00814434020073 Catalog Number : CI 106, CI 106/ITL

Device Class :

Duns Number: 622223196

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

SteriTec Cross-Checks - 00814434020080 Catalog Number : CI 107/US

Device Class : 2

Duns Number: 622223196

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

SteriTec Cross-Checks S - 00814434020097 Catalog Number : CI 134/US

Device Class :

Duns Number: 622223196

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

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