Corporation Steris Canada

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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

Disinfector, medical devices (MEC) (6) Accessories, germicide, cleaning, for endoscopes (NZA) (4)

Premarket Exempt

No Yes

Clear

Reliance - 00724995193683 Catalog Number : MB000079

Device Description : The Reliance EPS Processor with base is intended for washing and high Level disi

Device Class : 2

Duns Number: 202659140

Premarket Exempt : No

Product Code : NZA

Prescription Use : No

Device Count : 1

Reliance - 00724995193690 Catalog Number : MB000080

Device Description : The Reliance EPS Processor with base is intended for washing and high Level disi

Device Class : 2

Duns Number: 202659140

Premarket Exempt : No

Product Code : NZA

Prescription Use : No

Device Count : 1

Reliance - 00724995193706 Catalog Number : MB000081

Device Description : The Reliance EPS Processor with base is intended for washing and high Level disi

Device Class : 2

Duns Number: 202659140

Premarket Exempt : No

Product Code : NZA

Prescription Use : No

Device Count : 1

NA - 00724995194420 Catalog Number : EPSC011INT

Device Description : The Flow Units are accessories that facilitate use of the Reliance EPS processor

Device Class : 2

Duns Number: 202659140

Premarket Exempt : No

Product Code : NZA

Prescription Use : No

Device Count : 1

AMSCO - 00724995195953 Catalog Number : FH120112

Device Description : The AMSCO 2532 Single-Chamber Washer Disinfector, Vented Unit with single door i

Device Class : 2

Duns Number: 202659140

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

AMSCO - 00724995196042 Catalog Number : FH14042S001

Device Description : The AMSCO 5052 Washer-Disinfector is designed for use in the cleaning and interm

Device Class : 2

Duns Number: 202659140

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

Reliance Vision - 00724995196066 Catalog Number : FH81043

Device Description : The Reliance Vision Multi-Chamber L-R Electric Unit is intended for use in the c

Device Class : 2

Duns Number: 202659140

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

Vision - 00724995196295 Catalog Number : FW06213

Device Description : The Vision 1321 Electric Heated Cart Washer Disinfector is a high-capacity mecha

Device Class : 2

Duns Number: 202659140

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

Vision - 00724995196325 Catalog Number : FW10204

Device Description : The Vision 1330L Cart and Utensil Washer-Disinfector is a high-capacity mechanic

Device Class : 2

Duns Number: 202659140

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

Vision - 00724995196332 Catalog Number : FW10213

Device Description : The Vision 1330L Cart and Utensil Washer-Disinfector with electric heat is a hig

Device Class : 2

Duns Number: 202659140

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

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