BIODERMIS CORPORATION

BIODERMIS CORPORATION

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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

Elastomer, Silicone, For Scar Management (MDA) (10)

Premarket Exempt

No

Clear

TOPIGEL - 00768627007078 Catalog Number : NC TPG-1112

Device Description : Topigel 11 1/2 x 1 2/5"

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

TOPIGEL - 00768627007085 Catalog Number : NC TPG-123

Device Description : Topigel 2 x 2 1/2"

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

TOPIGEL - 00768627007092 Catalog Number : NC TPG-146

Device Description : Topigel 5 5/8 x 4 5/8

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

TOPIGEL - 00768627007108 Catalog Number : NC TPG-46

Device Description : Topigel 5 5/8 x 4 5/8

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

TOPIGEL - 00768627007122 Catalog Number : NC TPG-1116

Device Description : Topigel 11 x 15 3/4"

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

TOPIGEL - 00768627007139 Catalog Number : NC TPG15461

Device Description : Topigel 4" x 1 3/8"

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

TOPIGEL - 00768627007146 Catalog Number : NC TPG 15460S

Device Description : TOPIGEL 1 1/2 x 3" SAMPLE

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00850014883010 Catalog Number : EDGTNT-2106

Device Description : TNT Silicone Strip 1.4" x 6.0". 2 Strips

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00850014883027 Catalog Number : EDGTNT-112

Device Description : TNT Strip 1.4" x 11.5". 1 Strip

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00850014883034 Catalog Number : FDG-112

Device Description : Fabric Strip 1.4" x 11.5". 1 Strip

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

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