FLEX OPERATING ROOM, LLC

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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 (KKX) (4)

Premarket Exempt

Clear

Dinamic OR Spine Rack Monitor Cover 60x64cm - 00869653000207 Catalog Number : Gerstner-Moncover-01A

Device Class : 2

Duns Number: 080180725

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Dinamic OR Gerstner Double Wide Orange Cover Labeled A1-A8 - 00869653000221 Catalog Number : 2000A-B

Device Class : 2

Duns Number: 080180725

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Dinamic OR Gerstner Double Wide Blue Cover Labeled B1-B8 - 00869653000238 Catalog Number : 2000B-B

Device Class : 2

Duns Number: 080180725

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Dinamic OR Gerstner Triple Wide Orange Cover Labeled A1-A12 - 00869653000245 Catalog Number : 3000A-B

Device Class : 2

Duns Number: 080180725

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

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