TOPIGEL NC TPG 15460S

GUDID 00768627007146

TOPIGEL 1 1/2 x 3" SAMPLE

BIODERMIS CORPORATION

Scar management dressing, reusable

• Primary Device ID: 00768627007146
• NIH Device Record Key: fdb10708-d83c-4dcf-90d8-dbfc457e11a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOPIGEL
• Version Model Number: NC TPG 15460S
• Catalog Number: NC TPG 15460S
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00768627007146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K913140

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: 2022-10-18
• Device Publish Date: 2022-10-10

On-Brand Devices [TOPIGEL]

• 00768627007146: TOPIGEL 1 1/2 x 3" SAMPLE
• 00768627007139: Topigel 4" x 1 3/8"
• 00768627007122: Topigel 11 x 15 3/4"
• 00768627007108: Topigel 5 5/8 x 4 5/8
• 00768627007092: Topigel 5 5/8 x 4 5/8
• 00768627007085: Topigel 2 x 2 1/2"
• 00768627007078: Topigel 11 1/2 x 1 2/5"