STERIS CORPORATION

Address:5960 Heisley Road,Mentor,OH,44060,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

TRAY, SURGICAL (LRP) (2) CHAIR, SURGICAL, AC-POWERED (GBB) (1)

Premarket Exempt

No Yes

Clear

NA - 50724995156393 Catalog Number : LB52

Device Description : The STERIS Harmony Surgical Light Handle Tray, Bulk Pack is used to maintain the The STERIS Harmony Surgical Light Handle Tray, Bulk Pack is used to maintain the shape of the bezel Bowl during sterilization and the packagin process.

Device Class : 1

Duns Number: 036985604

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1000

NA - 50724995203035 Catalog Number : LB55

Device Description : The Nonsterile Lighthandle Tray, Bulk Pack is used to maintain bowl-like shape d The Nonsterile Lighthandle Tray, Bulk Pack is used to maintain bowl-like shape during sterilization and packing process of sterilizable light handle covers.

Device Class : 1

Duns Number: 036985604

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1000

NA - 72499517978600 Catalog Number : BF594

Device Description : The Shoulder Chair is used for open or arthroscopic procedures, features a uniqu The Shoulder Chair is used for open or arthroscopic procedures, features a unique, multi axis head positioning capability, which allows for easy intubation and head posturing.

Device Class : 1

Duns Number: 036985604

Premarket Exempt : Yes

Product Code : GBB

Prescription Use : No

Device Count : 1

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