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 - 00854763005679 Catalog Number : SCG-5106

Device Description : Scar Aid C-Strip 1.4" x 6.0", 5 Pack

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005686 Catalog Number : SCG-1106

Device Description : Scar Aid C-Strip 1.4" x 6.0"

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005693 Catalog Number : SCLP-1

Device Description : Scar Aid Areopexy 2.75" OD x .75 ID x 5.90" L

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005709 Catalog Number : SCLP-51

Device Description : Scar Aid Areopexy 2.75" OD x .75 ID x 5.90" L, 5 Pair

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005716 Catalog Number : SCC-1

Device Description : Scar Aid EpiTab Circles 6-Pack 1.90 cm Diam.

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005723 Catalog Number : SCS-1

Device Description : Scar Aid EpiTab Squares 6-Pack 1.25" x 1.25"

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005730 Catalog Number : SCC-51

Device Description : Scar Aid EpiTab Circles 30-Pack 1.90 cm Diam.

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

SCAR AID - 00854763005747 Catalog Number : SCS-51

Device Description : Scar Aid EpiTab Squares 30-Pack 1.25" x 1.25"

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-FOAM - 00854763005754 Catalog Number : EPFU-1

Device Description : Epifoam Uncoated Pads (1 pad per pouch).

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

EPI-FOAM - 00854763005761 Catalog Number : EPF-1

Device Description : EpIfoam Silicone-Backed Adhesive Pad (1 pad per pouch)

Device Class : 1

Duns Number: 809650005

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

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