STERIS CORPORATION

Address:7501 Page Ave,Saint Louis,MO,63133,US

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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) (7) Biological sterilization process indicator with recombinant-dna plasmid (OWP) (1) Sterilant, medical devices (MED) (1) Sterilization wrap containers, trays, cassettes & other accessories (KCT) (1)

Premarket Exempt

No Yes

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NA - 00724995001674 Catalog Number : QKC1763E

Device Description : The Quick Connect for Karl Storz GI Silver Scope Video Endoscopes with Water Jet The Quick Connect for Karl Storz GI Silver Scope Video Endoscopes with Water Jet is used with C1160E Universal Flexible Processing Tray in the SYSTEM 1E and/or SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems.

Device Class : 2

Duns Number: 868205779

Premarket Exempt : No

Product Code : MED

Prescription Use : No

Device Count : 1

VERIFY - 00724995002534 Catalog Number : PCC070

Device Description : The VERIFY VH202 Indicator Tape is intended to secure items wrapped in synthetic The VERIFY VH202 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change. It can be changed in all V-PRO Low Temperature Sterilization Systems and Sterrad 100S, NX and 100NX Sterilizers.

Device Class :

Duns Number: 961394798

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

VERIFY - 00724995002541 Catalog Number : LCB030

Device Description : The VERIFY Incubator is for exclusive use with VERIFY Assert Self-Contained Biol The VERIFY Incubator is for exclusive use with VERIFY Assert Self-Contained Biological Indicators and VERIFY Process Challenge Devices.

Device Class : 2

Duns Number: 868205779

Premarket Exempt : No

Product Code : OWP

Prescription Use : No

Device Count : 1

VERIFY - 00724995002558 Catalog Number : LCB035

Device Description : The VERIFY All-In-One STEAM Reusable Test Pack includes 1 test pack and 200 VERI The VERIFY All-In-One STEAM Reusable Test Pack includes 1 test pack and 200 VERIFY STEAM Integrating Indicators.

Device Class : 2

Duns Number: 040469731

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

VERIFY - 00724995002565 Catalog Number : LCB036

Device Description : The VERIFY All-In-One STEAM Reusable Test Pack with Step Counter includes 1 test The VERIFY All-In-One STEAM Reusable Test Pack with Step Counter includes 1 test pack with Step Counter and 200 VERIFY STEAM Integrating Indicators.

Device Class : 2

Duns Number: 040469731

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

VERIFY - 00724995002572 Catalog Number : LCB037

Device Description : The VERIFY All-In-One STEAM Reusable Test Pack with Tag includes 1 test pack wit The VERIFY All-In-One STEAM Reusable Test Pack with Tag includes 1 test pack with tag and 200 VERIFY STEAM Integrating Indicators.

Device Class : 2

Duns Number: 040469731

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

VERIFY - 00724995002589 Catalog Number : LCB039

Device Description : The VERIFY All-In-One STEAM Reusable Test Pack includes 2 test packs, 200 VERIFY The VERIFY All-In-One STEAM Reusable Test Pack includes 2 test packs, 200 VERIFY STEAM Integrating Indicators and 200 VERIFY All-In-One Bowie Dick Indicator Strips.

Device Class : 2

Duns Number: 040469731

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

VERIFY - 00724995002596 Catalog Number : LCB040

Device Description : The VERIFY All-In-One STEAM Reusable Test Pack with Step Counter includes 2 test The VERIFY All-In-One STEAM Reusable Test Pack with Step Counter includes 2 test packs with step counters, 200 VERIFY STEAM Integrating Indicators and 200 VERIFY All-In-One Bowie Dick Indicator Strips.

Device Class : 2

Duns Number: 040469731

Premarket Exempt : No

Product Code : JOJ

Prescription Use : Yes

Device Count : 1

VERIFY - 00724995002602 Catalog Number : LCB041

Device Description : The VERIFY All-In-One STEAM Reusable Test Pack with Tag includes 2 test packs wi The VERIFY All-In-One STEAM Reusable Test Pack with Tag includes 2 test packs with tags, 200 VERIFY STEAM Integrating Indicators and 200 VERIFY All-In-One Bowie Dick Indicator Strips.

Device Class : 2

Duns Number: 040469731

Premarket Exempt : No

Product Code : JOJ

Prescription Use : Yes

Device Count : 1

Pro-Lite - 00724995002749 Catalog Number : VP0045

Device Description : The PRO-LITE Sterilization Tray, 13-inch x 4.5-inch x 2.25-inch is used with the The PRO-LITE Sterilization Tray, 13-inch x 4.5-inch x 2.25-inch is used with the V-PRO Low Temperature Sterilization Systems and STERRAD NX, 100S and 100NX sterilizers.

Device Class : 2

Duns Number: 961394798

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

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