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) (5) Indicator, Biological Sterilization Process (FRC) (3) Indicator, Sterilization (LRT) (2)

Premarket Exempt

Clear

Getinge Assure S.M.A.R.T. Green Sterilizer Mechanical Air Removal Test - 00814434020745 Catalog Number : 61301606625

Device Class : 2

Duns Number: 622223196

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

Getinge Assured Smart-Read Biological Indicator, Getinge Assured AccuFast - 00814434020776 Catalog Number : 504054100, 61301606636, 61301606637

Device Description : 504054100 - Getinge Assured Smart-Read Biological Indicator - 100 ct.61301606636 504054100 - Getinge Assured Smart-Read Biological Indicator - 100 ct.61301606636 - Getinge Assured AccuFast Biological Indicator - 50 ct.61301606637 - Getinge Assured AccuFast Biological Indicator - 100 ct.

Device Class :

Duns Number: 622223196

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

Getinge Assured Self-Contained Biological Indicator Steam - 00814434020783 Catalog Number : 504053900

Device Class : 2

Duns Number: 622223196

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

Getinge Assured Self-Contained Biological Indicator EO - 00814434020790 Catalog Number : 504054000, 6130160671

Device Description : 504054000 - Case of 4 boxes of 1006130160671 - Box of 50

Device Class :

Duns Number: 622223196

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

SteriTec Green Tape 3/4" - 00814434020806 Catalog Number : CI 159/.75

Device Class : 2

Duns Number: 622223196

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

Getinge Assured Control Card - 00814434021186 Catalog Number : 61301606815

Device Class : 2

Duns Number: 622223196

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

Getinge Assured Steam Sterilization Indicator - 00814434021193 Catalog Number : 61301606813

Device Class : 2

Duns Number: 622223196

Premarket Exempt : No

Product Code : LRT

Prescription Use : No

Device Count : 1

Getinge Assured Steam Sterilization Indicator - 00814434021209 Catalog Number : 61301606814

Device Class : 2

Duns Number: 622223196

Premarket Exempt : No

Product Code : LRT

Prescription Use : No

Device Count : 1

Getinge Assured MI Steam Migrating Integrator Strip - 00814434021230 Catalog Number :

Device Class :

Duns Number: 622223196

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

SteriTec Green Tape 1" - 00814434021315 Catalog Number : CI 159/1

Device Class : 2

Duns Number: 622223196

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

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