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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

Absorbable Collagen Hemostatic Agent With Thrombin (PMX) (2) Cuff, Nerve (JXI) (2)

Premarket Exempt

Clear

COVA ORTHO NERVE - 03760193182583 Catalog Number : COUS46

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 - 03760193182590 Catalog Number : COUS68

Device Description : Collagen Guided Healing Membrane

Device Class : 2

Duns Number: 277619636

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

HEMOBLAST Bellows Laparoscopic Applicator - 03760193182668 Catalog Number : LAP01-US

Device Description : HEMOBLAST Bellows Laparoscopic Applicator is intended for delivery of HEMOBLAST HEMOBLAST Bellows Laparoscopic Applicator is intended for delivery of HEMOBLAST Bellows hemostatic powder to bleeding surgical sites through a 5mm or larger trocar.

Device Class :

Duns Number: 277619636

Premarket Exempt : No

Product Code : PMX

Prescription Use : Yes

Device Count : 1

HEMOBLAST Bellows - 03760193182705 Catalog Number : BQF02-US

Device Description : Hemostatic agent, including thrombin

Device Class :

Duns Number: 277619636

Premarket Exempt : No

Product Code : PMX

Prescription Use : Yes

Device Count : 1

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