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

Drape, surgical, exempt (PUI) (6)

Premarket Exempt

Yes

Clear

ORLocate - 05060356150007 Catalog Number : LC16601

Device Description : ORLocate Locator Drape with two straps, sterile is used with the ORLocate Sponge ORLocate Locator Drape with two straps, sterile is used with the ORLocate Sponge Solution System.

Device Class : 2

Duns Number: 177360039

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

ORLocate - 05060356150021 Catalog Number : HC12631

Device Description : ORLocate HoveRead Drape with two straps, sterile is used with the ORLocate Spon ORLocate HoveRead Drape with two straps, sterile is used with the ORLocate Sponge Solution System.

Device Class : 2

Duns Number: 177360039

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

ORLocate - 05060356150045 Catalog Number : LC16961

Device Description : ORLocate Locator Drape with three straps, sterile is used with the ORLocate Spon ORLocate Locator Drape with three straps, sterile is used with the ORLocate Sponge Solution System.

Device Class : 2

Duns Number: 177360039

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

ORLocate - 15060356150011 Catalog Number : LC16601NS

Device Description : ORLocate Locator Drape with two straps, non-sterile is used with the ORLocate Sp ORLocate Locator Drape with two straps, non-sterile is used with the ORLocate Sponge Solution System.

Device Class :

Duns Number: 177360039

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 10

ORLocate - 15060356150035 Catalog Number : HC12631NS

Device Description : ORLocate HoveRead Drape with two straps, non-sterile is used with the ORLocate S ORLocate HoveRead Drape with two straps, non-sterile is used with the ORLocate Sponge Solution System.

Device Class :

Duns Number: 177360039

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 10

ORLocate - 15060356150059 Catalog Number : LC16961NS

Device Description : ORLocate Locator Drape with three straps, non-sterile is used with the ORLocate ORLocate Locator Drape with three straps, non-sterile is used with the ORLocate Sponge Solution System.

Device Class :

Duns Number: 177360039

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 10

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