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

DRESSING, WOUND, COLLAGEN (KGN) (6) Mesh, surgical (FTM) (4)

Premarket Exempt

Clear

MatriStem - 00386190000762 Catalog Number : BMM0505

Device Description : Burn Matrix Meshed 5X5cm

Device Class : U

Duns Number: 137258252

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

MatriStem - 00386190000779 Catalog Number : BMM0710

Device Description : Burn Matrix Meshed 7X10cm

Device Class : U

Duns Number: 137258252

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

MatriStem - 00386190000786 Catalog Number : BMM1015

Device Description : Burn Matrix Meshed 10X15cm

Device Class : U

Duns Number: 137258252

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

MatriStem - 00386190000809 Catalog Number : WSM0505

Device Description : Multilayer Wound Matrix 5 X 5 cm

Device Class : U

Duns Number: 137258252

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

MatriStem - 00386190000816 Catalog Number : WSM0710

Device Description : Multilayer Wound Matrix 7 X 10 cm

Device Class : U

Duns Number: 137258252

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

MatriStem - 00386190000823 Catalog Number : WSM1015

Device Description : Multilayer Wound Matrix 10 X 15 cm

Device Class : U

Duns Number: 137258252

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

MatriStem - 00386190000830 Catalog Number : PFM0412

Device Description : Pelvic Floor Matrix 4 x 12 cm

Device Class : 2

Duns Number: 137258252

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

MatriStem - 00386190000847 Catalog Number : PFM0505

Device Description : Pelvic Floor Matrix 5 x 5 cm

Device Class : 2

Duns Number: 137258252

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

MatriStem - 00386190000854 Catalog Number : PFM0710

Device Description : Pelvic Floor Matrix 7 x 10 cm

Device Class : 2

Duns Number: 137258252

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

MatriStem - 00386190000861 Catalog Number : PFM1015

Device Description : Pelvic Floor Matrix 10 x 15 cm

Device Class : 2

Duns Number: 137258252

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

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