FIRST AID BANDAGE CO INC

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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

Ear Wick (KCN) (7) Gauze/Sponge, Internal, X-Ray Detectable (GDY) (2) Sponge, Ophthalmic (HOZ) (1)

Premarket Exempt

No Yes

Clear

FABCO - 30634303800343 Catalog Number : Q604250

Device Description : Lasik Eye Sponge

Device Class :

Duns Number: 001137280

Premarket Exempt : No

Product Code : HOZ

Prescription Use : No

Device Count : 3

FABCO - 30634303800374 Catalog Number : Q605201

Device Description : Ear Wick

Device Class : 1

Duns Number: 001137280

Premarket Exempt : Yes

Product Code : KCN

Prescription Use : No

Device Count : 1

FABCO - 30634303800381 Catalog Number : Q605202

Device Description : Ear Wick

Device Class : 1

Duns Number: 001137280

Premarket Exempt : Yes

Product Code : KCN

Prescription Use : No

Device Count : 1

FABCO - 30634303800398 Catalog Number : Q605203

Device Description : Large Post-Op Packing

Device Class : 1

Duns Number: 001137280

Premarket Exempt : Yes

Product Code : KCN

Prescription Use : No

Device Count : 1

FABCO - 30634303800404 Catalog Number : Q605204

Device Description : Small Post-Op Ear Packing

Device Class : 1

Duns Number: 001137280

Premarket Exempt : Yes

Product Code : KCN

Prescription Use : No

Device Count : 1

FABCO - 30634303800411 Catalog Number : Q605205

Device Description : Fenestrated Ear Wick

Device Class : 1

Duns Number: 001137280

Premarket Exempt : Yes

Product Code : KCN

Prescription Use : No

Device Count : 1

FABCO - 30634303800428 Catalog Number : Q605206

Device Description : Fenestrated Ear Wick

Device Class : 1

Duns Number: 001137280

Premarket Exempt : Yes

Product Code : KCN

Prescription Use : No

Device Count : 1

FABCO - 30634303800435 Catalog Number : Q605300

Device Description : PVA Headband, Surgical

Device Class : 1

Duns Number: 001137280

Premarket Exempt : Yes

Product Code : KCN

Prescription Use : No

Device Count : 1

FABCO - 30634303800442 Catalog Number : Q606106

Device Description : Femoral Canal Sponge 6 in

Device Class : 1

Duns Number: 001137280

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : No

Device Count : 1

FABCO - 30634303800459 Catalog Number : Q606108

Device Description : Femoral Canal Sponge 8 in

Device Class : 1

Duns Number: 001137280

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : No

Device Count : 1

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