Corporation Steris Canada

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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

UNIT, DRYING (JRJ) (7) Sterilant, medical devices (MED) (2) Disinfector, medical devices (MEC) (1)

Premarket Exempt

No Yes

Clear

SYSTEM 1 endo Liquid Chemical Sterilant Processing System - 00724995155728 Catalog Number : P6800

Device Description : The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemic The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilant processor designed to safely and effectively reprocess heat-sensitive, semi-critical medical devices.

Device Class : 2

Duns Number: 202659140

Premarket Exempt : No

Product Code : MED

Prescription Use : No

Device Count : 1

NA - 00724995157449 Catalog Number : C3000XL

Device Description : The Ultrasound Processing Tray is used in the SYSTEM 1E and SYSTEM 1 endo Liquid The Ultrasound Processing Tray is used in the SYSTEM 1E and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems.

Device Class : 2

Duns Number: 202659140

Premarket Exempt : No

Product Code : MED

Prescription Use : No

Device Count : 1

NA - 00724995162221 Catalog Number : FD039

Device Description : The Amsco 2532 Four Level Manifold Rack is used with the AMSCO 2532 Washer Disinfector.

Device Class : 2

Duns Number: 202659140

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

AMSCO - 00724995162610 Catalog Number : DCR100101

Device Description : The AMSCO Drying Cabinet, 29-inch with Pass Through delivers unrivaled precision The AMSCO Drying Cabinet, 29-inch with Pass Through delivers unrivaled precision with exact temperature control, timers for every shelf and HEPA filtration.

Device Class : 1

Duns Number: 202659140

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 1

AMSCO - 00724995162627 Catalog Number : DCC100101

Device Description : The AMSCO Drying Cabinet, 29-inch delivers unrivaled precision with exact temper The AMSCO Drying Cabinet, 29-inch delivers unrivaled precision with exact temperature control, timers for every shelf and HEPA filtration.

Device Class : 1

Duns Number: 202659140

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 1

AMSCO - 00724995162634 Catalog Number : DCR200101

Device Description : The AMSCO Drying Cabinet, 38-inch Pass Through delivers unrivaled precision with The AMSCO Drying Cabinet, 38-inch Pass Through delivers unrivaled precision with exact temperature control, timers for every shelf and HEPA filtration.

Device Class : 1

Duns Number: 202659140

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 1

AMSCO - 00724995162641 Catalog Number : DCC200101

Device Description : The AMSCO Drying Cabinet, 38-inch delivers unrivaled precision with exact temper The AMSCO Drying Cabinet, 38-inch delivers unrivaled precision with exact temperature control, timers for every shelf and HEPA filtration.

Device Class : 1

Duns Number: 202659140

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 1

AMSCO - 00724995162658 Catalog Number : DCR101101

Device Description : The AMSCO Drying Cabinet, 29-inch with Pass Through and Purge delivers unrivaled The AMSCO Drying Cabinet, 29-inch with Pass Through and Purge delivers unrivaled precision with exact temperature control, timers for every shelf and HEPA filtration.

Device Class : 1

Duns Number: 202659140

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 1

AMSCO - 00724995162665 Catalog Number : DCC101101

Device Description : The AMSCO Drying Cabinet, 29-inch with Purge delivers unrivaled precision with e The AMSCO Drying Cabinet, 29-inch with Purge delivers unrivaled precision with exact temperature control, timers for every shelf and HEPA filtration.

Device Class : 1

Duns Number: 202659140

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 1

AMSCO - 00724995162672 Catalog Number : DCR201101

Device Description : The AMSCO Drying Cabinet, 38-inch with Pass Through and Purge delivers unrivaled The AMSCO Drying Cabinet, 38-inch with Pass Through and Purge delivers unrivaled precision with exact temperature control, timers for every shelf and HEPA filtration.

Device Class : 1

Duns Number: 202659140

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 1

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