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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

Mesh, Surgical, Polymeric (FTL) (4) Barrier, Animal Source, Intraoral (NPL) (3) Cuff, Nerve (JXI) (3)

Premarket Exempt

Clear

COVAMESH - 03760193182101 Catalog Number : CVM2015US

Device Description : Polyester mesh coated with collagen membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

COVAMESH - 03760193182118 Catalog Number : CVM2520US

Device Description : Polyester mesh coated with collagen membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

COVAMESH - 03760193182125 Catalog Number : CVM3020US

Device Description : Polyester mesh coated with collagen membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

COVAMESH - 03760193182132 Catalog Number : CVM16RUS

Device Description : Polyester mesh coated with collagen membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

COVAMAX - 03760193182194 Catalog Number : COV12DUS

Device Description : Collagen Guided Healing Membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

COVAMAX - 03760193182200 Catalog Number : COV23DUS

Device Description : Collagen Guided Healing Membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

COVAMAX - 03760193182217 Catalog Number : COV34DUS

Device Description : Collagen Guided Healing Membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

COVA ORTHO NERVE - 03760193182552 Catalog Number : COUS12

Device Description : Collagen Guided Healing Membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

COVA ORTHO NERVE - 03760193182569 Catalog Number : COUS23

Device Description : Collagen Guided Healing Membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

COVA ORTHO NERVE - 03760193182576 Catalog Number : COUS34

Device Description : Collagen Guided Healing Membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

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