SCAR AID SCSTSP17-111

GUDID 00854763005945

Scar Aid SPF 15 Silicone Stick, 17g

BIODERMIS CORPORATION

Scar management dressing, reusable

• Primary Device ID: 00854763005945
• NIH Device Record Key: 505814a4-d518-479e-9d45-841853e3f945
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCAR AID
• Version Model Number: SCSTSP17-111
• Catalog Number: SCSTSP17-111
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854763005945 [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