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 - 00852260000494 Catalog Number : EDGTNT-5116

Device Description : TNT Large Sheet, 11" x 15.75", (28 x 40 x 0.09cm), 5 Pack

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000500 Catalog Number : EDGTNT-5112

Device Description : TNT Strip, 1.4" x 11.5", (3.60 x 29.0 x 0.09cm), 5 Pack

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000517 Catalog Number : EDGTNT-5106

Device Description : TNT C-Strip, 1.4" x 6.0", (3.6 x 15 x 0.09cm), 5 Pack

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000524 Catalog Number : EDGTNT-46

Device Description : TNT Standard Sheet, 4.5" x 5.7", (12 x 14.5 x 0.09cm), 5 Pack

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000531 Catalog Number : EDGTNT-146

Device Description : TNT Standard Sheet, 4.7" x 5.7", (12 x 14.5 x 0.09cm), 1 Sheet

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000548 Catalog Number : EDGTNT-123

Device Description : TNT Patch, 2" x 2.5", (5.0 x 6.0 x 0.09cm), 1 Pair

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000555 Catalog Number : EDGTNT-1116

Device Description : TNT Large Sheet, 11" x 15.75" (28 x 40 x 0.09cm), 1 Large Sheet

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000562 Catalog Number : EDGTNT-1112

Device Description : TNT, Strip, 1.4" x 11.5", (3.60 x 29.0 x 0.09cm) , 1 Pair

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000579 Catalog Number : EDGTNT-1106

Device Description : TNT C-Strip, 1.4" x 6.0", (3.6 x 15 x 0.09cm), 1 C-Strip

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-DERM - 00852260000586 Catalog Number : EDG-5123

Device Description : Patch 2 x 2.5 in. (5 x 6 cm). 5 Pair

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

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