Keranetics, Inc.

Address:200 East First Street,Winston Salem,NC,27101,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

Dressing, Wound, Collagen (KGN) (3)

Premarket Exempt

Clear

KeraStat Gel - B789P00100 Catalog Number :

Device Description : Sterile, non-implantable, water-based gelatinous (hydrogel) wound dressing

Device Class :

Duns Number: 081252398

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

KeraStat Cream - B789P00200 Catalog Number :

Device Description : Non-sterile, non-implantable wound dressing

Device Class : U

Duns Number: 081252398

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

KeraStat Cream - B789P00210 Catalog Number :

Device Description : Non-sterile, non-implantable wound dressing

Device Class : U

Duns Number: 081252398

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

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