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) (8) Mesh, surgical, collagen, plastic and reconstructive surgery (OXH) (8) Mesh, surgical, collagen, diaphragmatic hernia (OWV) (3) Mesh, surgical, collagen, large abdominal wall defects (OXK) (3) DRESSING, WOUND, COLLAGEN (KGN) (2)

Premarket Exempt

Clear

Gentrix® - 00386190001783 Catalog Number : PSMT1640

Device Description : Surgical Matrix Thick 16 x 40 cm

Device Class : 2

Duns Number: 137258252

Premarket Exempt : No

Product Code : FTM, OXH, OXK

Prescription Use : Yes

Device Count : 1

Gentrix® - 00386190001790 Catalog Number : PSMT1620

Device Description : Surgical Matrix Thick 16 x 20 cm

Device Class : 2

Duns Number: 137258252

Premarket Exempt : No

Product Code : FTM, OXK, OXH

Prescription Use : Yes

Device Count : 1

Gentrix® - 00386190001813 Catalog Number : PSMT1020

Device Description : Surgical Matrix Thick 10 x 20 cm

Device Class : 2

Duns Number: 137258252

Premarket Exempt : No

Product Code : OXK, FTM, OXH

Prescription Use : Yes

Device Count : 1

Cytal® - 00386190001820 Catalog Number : WSR1625

Device Description : Wound Matrix 3-Layer 16 x 25 cm

Device Class : U

Duns Number: 137258252

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

Cytal® - 00386190001837 Catalog Number : WSR1635

Device Description : Wound Matrix 3-Layer 16 x 35 cm

Device Class : U

Duns Number: 137258252

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

Gentrix® - 00386190001844 Catalog Number : PSMX0505

Device Description : Surgical Matrix 5 x 5 cm

Device Class : 2

Duns Number: 137258252

Premarket Exempt : No

Product Code : OWV, FTM, OXH

Prescription Use : Yes

Device Count : 1

Gentrix® - 00386190001851 Catalog Number : PSMX0710

Device Description : Surgical Matrix 7 x 10 cm

Device Class : 2

Duns Number: 137258252

Premarket Exempt : No

Product Code : OWV, OXH, FTM

Prescription Use : Yes

Device Count : 1

Gentrix® - 00386190001868 Catalog Number : PSM0505

Device Description : Surgical Matrix Thin 5 x 5 cm

Device Class : 2

Duns Number: 137258252

Premarket Exempt : No

Product Code : FTM, OXH

Prescription Use : Yes

Device Count : 1

Gentrix® - 00386190001875 Catalog Number : PSMX1015

Device Description : Surgical Matrix 10 x 15 cm

Device Class : 2

Duns Number: 137258252

Premarket Exempt : No

Product Code : OXH, FTM, OWV

Prescription Use : Yes

Device Count : 1

Gentrix® - 00386190001882 Catalog Number : PSM0412

Device Description : Surgical Matrix Thin 4 x 12 cm

Device Class : 2

Duns Number: 137258252

Premarket Exempt : No

Product Code : OXH, FTM

Prescription Use : Yes

Device Count : 1

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