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

Clear

EPI-DERM - 00850014883041 Catalog Number : EDGTNT-23

Device Description : TNT Patch 2" x 2.5". 1 Patch

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00850014883058 Catalog Number : CDG-G1

Device Description : Camo Green, 1 Sheet 2.75" x 1.18".

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00850014883065 Catalog Number : CDG-P1

Device Description : Camo Pink, 1 Sheet 2.75" x 1.18".

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

THERAFOAM - 00850014883126 Catalog Number : TRRU-1

Device Description : Therafoam Uncoated Wraps 1 Pack

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

THERAFOAM - 00850014883133 Catalog Number : TRRU-6

Device Description : Therafoam Uncoated Wraps 6 Pack

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

XERAGEL - 00852260000012 Catalog Number : XSO-797

Device Description : Xeragel Tube 10g (0.33oz).

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000029 Catalog Number : FDG-N30

Device Description : Natural Fabric, 30 Sheets 2.75" x 1.18". (7cm x 3cm), 30 sheets/6 up

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000036 Catalog Number : FDG-N15

Device Description : Natural Fabric, 15 Pack 2.75" x 1.18". (7cm x 3cm), 5 sheets/3 up

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000043 Catalog Number : FDG-N6

Device Description : Natural Fabric, 6 Sheets 2.75" x 1.18". (7cm x 3cm), 6 Sheets

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000067 Catalog Number : FDG-N3

Device Description : Natural Fabric, 3 Sheets 2.75" x 1.18". (7cm x 3cm), 3 sheets

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

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