ACELL, INC.

Address:6640 Eli Whitney Dr Ste 200,Columbia,MD,21046,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

Mesh, surgical (FTM) (2) Mesh, surgical, collagen, large abdominal wall defects (OXK) (2) Mesh, surgical, collagen, plastic and reconstructive surgery (OXH) (2) Intracardiac patch or pledget, biologically derived (PSQ) (1)

Premarket Exempt

Clear

Cardion™ - 00386190002087 Catalog Number : PP1015

Device Description : for Pericardial Repair, 10 x 15 cm

Device Class : 2

Duns Number: 137258252

Premarket Exempt : No

Product Code : PSQ

Prescription Use : Yes

Device Count : 1

Gentrix® - 00386190002681 Catalog Number : PSMT1620

Device Description : Surgical Matrix Thick 16 x 20 cm

Device Class : 2

Duns Number: 137258252

Premarket Exempt : No

Product Code : OXH, OXK, FTM

Prescription Use : Yes

Device Count : 1

Gentrix® - 00386190002698 Catalog Number : PSMT1020

Device Description : Surgical Matrix Thick 10 x 20 cm

Device Class : 2

Duns Number: 137258252

Premarket Exempt : No

Product Code : FTM, OXK, OXH

Prescription Use : Yes

Device Count : 1

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