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

DERMASOF - 00854763005242 Catalog Number : DSG-145

Device Description : Mini Single sheet 5.7" x 2.5". 1 Sheet

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005259 Catalog Number : SFG-1106

Device Description : Scar Aid Fabric C-Strip 1.4" x 6.0", 1 Strip

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005266 Catalog Number : SFG-5106

Device Description : Scar Aid Fabric C-Strip 1.4" x 6.0", 5 Strips

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

DERMASOF - 00854763005495 Catalog Number : DSG-5176

Device Description : Square sheet 3" x 2.5". 5 Sheets

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

DERMASOF - 00854763005501 Catalog Number : DSG-5145

Device Description : Mini Single sheet 5.7" x 2.5". 5 Sheets

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-FOAM - 00854763005525 Catalog Number : EPFU-3

Device Description : Epifoam Uncoated Pads (3 pads per pouch)

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-FOAM - 00854763005532 Catalog Number : EPFU-30

Device Description : Epifoam Uncoated Pads (30 pads per case).

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-FOAM - 00854763005549 Catalog Number : EPFU-W6

Device Description : Uncoated Epifoam Adhesive Wrap (6 wraps 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

SCAR AID - 00854763005556 Catalog Number : SCG-46

Device Description : Scar Aid Standard sheet 4.7" x 5.7", 5 Pack

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005563 Catalog Number : SCG-146

Device Description : Scar Aid Standard sheet 4.7" x 5.7"

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

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