SCAR AID SCS-51

GUDID 00854763005747

Scar Aid EpiTab Squares 30-Pack 1.25" x 1.25"

BIODERMIS CORPORATION

Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable

• Primary Device ID: 00854763005747
• NIH Device Record Key: afc84c61-4bbc-4a86-b0ae-f5a84a0a5caa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCAR AID
• Version Model Number: SCS-51
• Catalog Number: SCS-51
• Company DUNS: 809650005
• Company Name: BIODERMIS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com
• Phone: 702-260-4466
• Email: customerservice@scaraid.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854763005747 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992146

FDA Product Code

• MDA: Elastomer, Silicone, For Scar Management

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-04
• Device Publish Date: 2020-08-27

On-Brand Devices [SCAR AID]

• 00854763005976: Scar Aid Fabric 6 Up, 30 Sheets 2.75" x 1.18",
• 00854763005969: Scar Aid Fabric, 3 Up, 15 Pack 2.75" x 1.18"
• 00854763005945: Scar Aid SPF 15 Silicone Stick, 17g
• 00854763005938: Scar Aid SPF 15 Silicone Stick, 4.25g
• 00854763005921: Scar Aid Kids Silicone Stick, 17g
• 00854763005914: Scar Aid Kids Silicone Stick, 4.25g
• 00854763005907: Scar Aid Silicone Stick, 17g
• 00854763005891: Scar Aid Stick, 4.25g
• 00854763005884: Scar Aid Ointment Tube 10g
• 00854763005747: Scar Aid EpiTab Squares 30-Pack 1.25" x 1.25"
• 00854763005730: Scar Aid EpiTab Circles 30-Pack 1.90 cm Diam.
• 00854763005723: Scar Aid EpiTab Squares 6-Pack 1.25" x 1.25"
• 00854763005716: Scar Aid EpiTab Circles 6-Pack 1.90 cm Diam.
• 00854763005709: Scar Aid Areopexy 2.75" OD x .75 ID x 5.90" L, 5 Pair
• 00854763005693: Scar Aid Areopexy 2.75" OD x .75 ID x 5.90" L
• 00854763005686: Scar Aid C-Strip 1.4" x 6.0"
• 00854763005679: Scar Aid C-Strip 1.4" x 6.0", 5 Pack
• 00854763005662: Scar Aid Areola Circles 3" x 0.75", 5 Pack
• 00854763005655: Scar Aid Mastopexy-L/R 12.6" x 3.8"
• 00854763005648: Scar Aid Large 11" x 15.75", 5 Pack.
• 00854763005631: Scar Aid Strip 1.4" x 11.5", 5 Pack
• 00854763005624: Scar Aid Patch 2" x 2.5", 5 Pack
• 00854763005617: Scar Aid Areola Circles 3" x 0.75", 1 Pair
• 00854763005600: Scar Aid Mastopexy L/R 12.6" x 3.8"
• 00854763005594: Scar Aid Large Sheet 11" x 15.75"
• 00854763005587: Scar Aid Strip 1.4" x 11.5"
• 00854763005570: Scar Aid Patch 2" x 2.5"
• 00854763005563: Scar Aid Standard sheet 4.7" x 5.7"
• 00854763005556: Scar Aid Standard sheet 4.7" x 5.7", 5 Pack
• 00854763005266: Scar Aid Fabric C-Strip 1.4" x 6.0", 5 Strips
• 00854763005259: Scar Aid Fabric C-Strip 1.4" x 6.0", 1 Strip
• 00854763005204: Scar Aid Fabric, 6 Up Sheets 2.75" x 1.18", 6 sheets per box.
• 00854763005198: Scar Aid Fabric, 3 Up Sheets 2.75" x 1.18", 3 sheets per box.
• 00854763005181: Scar Aid Fabric Mastopexy-L/R 12.6" x 3.8", 5 Pair
• 00854763005174: Scar Aid Fabric Mastopexy-L/R 12.6" x 3.8", 1 pair
• 00854763005167: Scar Aid Fabric Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 5 pair
• 00854763005150: Scar Aid Fabric Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 1 pair
• 00854763005143: Scar Aid Fabric Areola Circles, 3" x 0.75", 5 Pair
• 00854763005136: Scar Aid Fabric Areola Circles 3" x 0.75", 1 Pair
• 00854763005129: Scar Aid Fabric EpiTab Squares 30-Pack 1.25" x 1.25"
• 00854763005112: Scar Aid Fabric EpiTab Squares 6-Pack 1.25" x 1.25"
• 00854763005105: Scar Aid Fabric EpiTab Circles 30-Pack 1.90 cm Diam.
• 00854763005099: Scar Aid Fabric EpiTab Circles 6-Pack 1.90 cm Diam.
• 00854763005082: Scar Aid Fabric Patch 2" x 2.5", 5 Pair
• 00854763005075: Scar Aid Fabric Patch 2" x 2.5", 1 Pair
• 00854763005068: Scar Aid Fabric Strip 1.4" x 11.5", 5 Pair
• 00854763005051: Scar Aid Fabric Strip 1.4" x 11.5", 1 Pair
• 00854763005044: Scar Aid Fabric Large Sheet 11" x 15.25", 5 Pack
• 00854763005037: Scar Aid Fabric Large Sheet 11" x 15.25"
• 00854763005020: Scar Aid Fabric Standard sheet 4.7" x 5.7", 5 Pack