InnovaBurn

GUDID 00850002643442

6cm x 6cm Porcine Placenta Derived ECM

Triad Life Sciences, Inc.

Collagen wound matrix dressing

• Primary Device ID: 00850002643442
• NIH Device Record Key: 3eb68165-04f2-4dd9-9073-fbe70e7d8859
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InnovaBurn
• Version Model Number: IMB-0606-01
• Company DUNS: 081037338
• Company Name: Triad Life Sciences, Inc.
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002643442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213716

FDA Product Code

• KGN: Wound Dressing With Animal-Derived Material(S)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-17
• Device Publish Date: 2025-01-09

On-Brand Devices [InnovaBurn]

• 00850002643473: 10cm x 12cm Porcine Placenta Derived ECM
• 00850002643466: 8cm x 10cm Porcine Placenta Derived ECM
• 00850002643459: 7cm x 7cm Porcine Placenta Derived ECM
• 00850002643442: 6cm x 6cm Porcine Placenta Derived ECM