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

SCAR AID - 00854763005570 Catalog Number : SCG-123

Device Description : Scar Aid Patch 2" x 2.5"

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005587 Catalog Number : SCG-1112

Device Description : Scar Aid Strip 1.4" x 11.5"

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005594 Catalog Number : SCG-1116

Device Description : Scar Aid Large Sheet 11" x 15.75"

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005600 Catalog Number : SCMP-1

Device Description : Scar Aid Mastopexy L/R 12.6" x 3.8"

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005617 Catalog Number : SCAC-1

Device Description : Scar Aid Areola Circles 3" x 0.75", 1 Pair

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005624 Catalog Number : SCG-5123

Device Description : Scar Aid Patch 2" x 2.5", 5 Pack

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005631 Catalog Number : SCG-5112

Device Description : Scar Aid Strip 1.4" x 11.5", 5 Pack

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005648 Catalog Number : SCG-5116

Device Description : Scar Aid Large 11" x 15.75", 5 Pack.

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005655 Catalog Number : SCMP-51

Device Description : Scar Aid Mastopexy-L/R 12.6" x 3.8"

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005662 Catalog Number : SCAC-51

Device Description : Scar Aid Areola Circles 3" x 0.75", 5 Pack

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

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