XERAGEL XSO-797

GUDID 00852260000012

Xeragel Tube 10g (0.33oz).

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: 00852260000012
• NIH Device Record Key: 61ae0cee-440d-4d7d-bef5-688b375ffe15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XERAGEL
• Version Model Number: XSO-797
• Catalog Number: XSO-797
• 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: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com
• Phone: 7022604466
• Email: info@biodermis.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852260000012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003948

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

Devices Manufactured by BIODERMIS CORPORATION

• 00850014883270 - SCAR AID: 2023-04-26 1 Silicone Roll, 1.5" x 120" (4cm x 300cm)
• 00850014883287 - SCAR AID: 2023-04-26 4 Pack Silicone Strips, 5.7" x 1.57" (15cm x 4cm)
• 00850014883171 - SCAR AID: 2023-03-20 Scar Aid Silicone Stick 4.25g
• 00850014883188 - SCAR AID: 2023-03-20 SCAR AID SILICONE STICK 17g
• 00850014883195 - SCAR AID: 2023-03-20 Scar Aid Silicone Stick SPF 4.25g
• 00850014883201 - SCAR AID: 2023-03-20 Scar Aid Silicone Stick SPF 17g
• 00768627007078 - TOPIGEL: 2022-10-18 Topigel 11 1/2 x 1 2/5"
• 00768627007085 - TOPIGEL: 2022-10-18 Topigel 2 x 2 1/2"