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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

Cuff, Nerve (JXI) (5) Barrier, Animal Source, Intraoral (NPL) (3) Mesh, Surgical, Polymeric (FTL) (2)

Premarket Exempt

Clear

SALVIN RENOVIX - 03760193181975 Catalog Number : RENOVIX-15x25

Device Description : Collagen Guided Healing Membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

SALVIN RENOVIX - 03760193181982 Catalog Number : RENOVIX-20x30

Device Description : Collagen Guided Healing Membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

SALVIN RENOVIX - 03760193181999 Catalog Number : RENOVIX-30x40

Device Description : Collagen Guided Healing Membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

COVAORTHO-NERVE - 03760193182019 Catalog Number : COVO12

Device Description : Collagen Guided Healing Membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

COVAORTHO-NERVE - 03760193182026 Catalog Number : COVO23

Device Description : Collagen Guided Healing Membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

COVAORTHO-NERVE - 03760193182033 Catalog Number : COVO34

Device Description : Collagen Guided Healing Membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

COVAORTHO-NERVE - 03760193182040 Catalog Number : COVO46

Device Description : Collagen Guided Healing Membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

COVAORTHO-NERVE - 03760193182057 Catalog Number : COVO68

Device Description : Collagen Guided Healing Membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

COVAMESH - 03760193182088 Catalog Number : CVM12RUS

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 - 03760193182095 Catalog Number : CVM1510US

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

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