XERAGEL XSO-797

GUDID 00852260000012

Xeragel Tube 10g (0.33oz).

BIODERMIS CORPORATION

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"