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 - 00854763005877 Catalog Number : FDG-646

Device Description : Natural Fabric Standard sheet 4.7" x 5.7", 6 Sheets

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005884 Catalog Number : SCSO-797

Device Description : Scar Aid Ointment Tube 10g

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005891 Catalog Number : SCST-111

Device Description : Scar Aid Stick, 4.25g

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005907 Catalog Number : SCST17-111

Device Description : Scar Aid Silicone Stick, 17g

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005914 Catalog Number : SCSKT-111

Device Description : Scar Aid Kids Silicone Stick, 4.25g

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005921 Catalog Number : SCSKT17-111

Device Description : Scar Aid Kids Silicone Stick, 17g

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005938 Catalog Number : SCSTSP-111

Device Description : Scar Aid SPF 15 Silicone Stick, 4.25g

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005945 Catalog Number : SCSTSP17-111

Device Description : Scar Aid SPF 15 Silicone Stick, 17g

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005969 Catalog Number : SFG-N15

Device Description : Scar Aid Fabric, 3 Up, 15 Pack 2.75" x 1.18"

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005976 Catalog Number : SFG-N30

Device Description : Scar Aid Fabric 6 Up, 30 Sheets 2.75" x 1.18",

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

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