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

PRO-SIL - 00852260000296 Catalog Number : PROSP17-111

Device Description : Pro-Sil SPF 15 17g

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000302 Catalog Number : FMP-1

Device Description : Natural Fabric Mastopexy-L/R 12.6" x 3.8" (32. x 9.63 cm). 1 Pair

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000319 Catalog Number : FDG-5123

Device Description : Natural Fabric Patch 2" x 2.5" (5 x 6 cm). 5 Pair

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000326 Catalog Number : FDG-5116

Device Description : Natural Fabric Large sheet 11" x 15.25" (28 x 39 cm). 5 Large Sheets

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000333 Catalog Number : FDG-5112

Device Description : Natural Fabric Strip 1.4" x 11.5" (3.6 x 29 cm) 5 Pair

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000340 Catalog Number : FDG-5106

Device Description : Natural Fabric C-Strip 1.4" x 6.0" (3.6 x 15 cm), 5 C-Strips

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000357 Catalog Number : FDG-46

Device Description : Natural Fabric Standard sheet 4.7" x 5.7" (12 x 14.5 cm). 5 Sheets

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000364 Catalog Number : FDG-146

Device Description : Natural Fabric Standard sheet 4.7" x 5.7" (12 x 14.5 cm). 1 Sheet

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000371 Catalog Number : FDG-123

Device Description : Natural Fabric Patch 2" x 2.5" (5 x 6 cm). 1 Pair

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000388 Catalog Number : FDG-1116

Device Description : Natural Fabric Large sheet 11" x 15.25" (28 x 39 cm). 1 Large Sheet

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

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