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-FOAM - 00854763005778 Catalog Number : EPF-3

Device Description : Epifoam Adhesive Wrap (1 Wrap ) 36"x 11.75"x 0.375"

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-FOAM - 00854763005785 Catalog Number : EPF-W6

Device Description : Epifoam Adhesive Wrap (6 sheets per case) 36"x 11.75"x 0.375"

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-FOAM - 00854763005792 Catalog Number : EPFU-W

Device Description : Uncoated Epifoam Adhesive Wrap (1 wrap) 36"x 11.75"x 0.375"

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

THERAFOAM - 00854763005808 Catalog Number : TRP-1

Device Description : Therafoam Adhesive-Backed Pads (1 pad per pouch)

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

THERAFOAM - 00854763005815 Catalog Number : TRP-3

Device Description : Therafoam Adhesive-Backed Pads (3 pads per pouch)

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

THERAFOAM - 00854763005822 Catalog Number : TRP-30

Device Description : Therafoam Adhesive Backed Foam 10 Packs per case

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

THERAFOAM - 00854763005839 Catalog Number : TRPU-1

Device Description : Therafoam Uncoated Foam 1 Pack

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

THERAFOAM - 00854763005846 Catalog Number : TRPU-3

Device Description : Therafoam Uncoated Foam 3 Pack

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

THERAFOAM - 00854763005853 Catalog Number : TRPU-30

Device Description : Therafoam Uncoated Foam 30 pack

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00854763005860 Catalog Number : EDGTNT-646

Device Description : TNT Standard sheet 4.7" x 5.7", 6 Sheets

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

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