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 - 00852260000395 Catalog Number : FDG-1112

Device Description : Natural Fabric Strip 1.4" x 11.5" (3.6 x 29 cm) 1 Pair

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000401 Catalog Number : FDG-1106

Device Description : Natural Fabric C-Strip 1.4" x 6.0" (3.6 x 15 cm), 1 C-Strip

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000418 Catalog Number : FAC-51

Device Description : Natural Fabric Areola Circles 3" x .75" (7.60 x 1.90cm). 5 Pair

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000425 Catalog Number : FAC-1

Device Description : Natural Fabric Areola Circles 3" x .75". (7.60 x 1.90cm). 1 Pair

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPIFOAM - 00852260000432 Catalog Number : EPF-30

Device Description : Epifoam Adhesive Pads (30 pads per case) 7.75"x 11.5"x 0.5"

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000449 Catalog Number : EMPTNT-51

Device Description : TNT Mastopexy-L/R 12.6" x 3.8", (32 x 9.63 x 0.09 cm), 5 Pair

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000456 Catalog Number : EMPTNT-1

Device Description : TNT Mastopexy-L/R 12.6" x 3.8", (32 x 9.63 x 0.09 cm), 1 Pair

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000463 Catalog Number : EMP-51

Device Description : Mastopexy-L/R 12.6 x 3.8 in. (32. x 9.63 cm). 5 Pair

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000470 Catalog Number : EMP-1

Device Description : Mastopexy-L/R 12.6 x 3.8 in. (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 - 00852260000487 Catalog Number : EDGTNT-5123

Device Description : TNT, Patch 2" x 2.5", (5.0 x 6.0 x 0.09cm), 5 Pack

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

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