STERIS CORPORATION

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

Sterilant, medical devices (MED) (6) Cleaner, ultrasonic, medical instrument (FLG) (4)

Premarket Exempt

No Yes

Clear

NA - 00724995000103 Catalog Number : QLC1759E

Device Description : The Quick Connect for Olympus TGF-UC180J Ultrasound Gastroscope used with C1160E The Quick Connect for Olympus TGF-UC180J Ultrasound Gastroscope 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

NA - 00724995000615 Catalog Number : QFC1760E

Device Description : The Quick Connect for Fujifilm 530/580/600 Series GI Endoscopes is used with C11 The Quick Connect for Fujifilm 530/580/600 Series GI Endoscopes 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

Prolystica - 00724995000684 Catalog Number : 1C15T4

Device Description : Prolystica Ultra Concentrate HP Neutral 5 Liter is designed for use in hospital Prolystica Ultra Concentrate HP Neutral 5 Liter is designed for use in hospital washer-disinfector units and automated mechanical washers.

Device Class : 1

Duns Number: 139424188

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 1

Prolystica - 00724995000707 Catalog Number : 1C15T6

Device Description : Prolystica Ultra Concentrate HP Neutral 10 Liter is designed for use in hospital Prolystica Ultra Concentrate HP Neutral 10 Liter is designed for use in hospital washer-disinfector units and automated mechanical washers.

Device Class : 1

Duns Number: 139424188

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 1

Prolystica - 00724995000721 Catalog Number : 1C17T4

Device Description : Prolystica Ultra Concentrate HP Alkaline 5 Liter is designed for automated clean Prolystica Ultra Concentrate HP Alkaline 5 Liter is designed for automated cleaning, which includes hospital washer-disinfector units and automated mechanical washers.

Device Class : 1

Duns Number: 139424188

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 1

Prolystica - 00724995000738 Catalog Number : 1C17T6

Device Description : Prolystica Ultra Concentrate HP Alkaline 10 Liter is designed for automated clea Prolystica Ultra Concentrate HP Alkaline 10 Liter is designed for automated cleaning, which includes hospital washer-disinfector units and automated mechanical washers.

Device Class : 1

Duns Number: 139424188

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 1

Revital-Ox Resert - 00724995000783 Catalog Number : 4455N9

Device Description : Revital-Ox Resert High Level Disinfectant is a reusable high level disinfectant Revital-Ox Resert High Level Disinfectant is a reusable high level disinfectant for processing semi-critical medical devices for which alternative methods of terminal processing are not suitable or available. It is for use in both manual soaking and automated endoscope processors. It must be used with Revital-Ox RESERT R60 Solution Test Strips.

Device Class : 2

Duns Number: 139424188

Premarket Exempt : No

Product Code : MED

Prescription Use : No

Device Count : 1

NA - 00724995001322 Catalog Number : QFC1764E

Device Description : The Quick Connect for FujiNon 530 Dual Channel GI Endoscopes are used with C1160 The Quick Connect for FujiNon 530 Dual Channel GI Endoscopes are used with C1160E Universal Flexible Processing Trays in the System 1E Liquid Chemical Processing System.

Device Class : 2

Duns Number: 868205779

Premarket Exempt : No

Product Code : MED

Prescription Use : No

Device Count : 1

NA - 00724995001445 Catalog Number : QMC1762E

Device Description : The Quick Connect for Endochoice Fuse GI Endoscopes is used with C1160E Universa The Quick Connect for Endochoice Fuse GI Endoscopes 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 : Yes

Device Count : 1

NA - 00724995001636 Catalog Number : QKC1761E

Device Description : The Quick Connect for Karl Storz GI Silver Scope Series Video Endoscopes used wi The Quick Connect for Karl Storz GI Silver Scope Series Video Endoscopes 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

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