DermaCol

GUDID 00714196391322

DERMARITE INDUSTRIES LLC

Collagen wound matrix dressing

• Primary Device ID: 00714196391322
• NIH Device Record Key: 101b225a-c8ba-4a75-9043-11027ceb5f62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DermaCol
• Version Model Number: 00303E
• Company DUNS: 883925562
• Company Name: DERMARITE INDUSTRIES LLC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00714196391322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060804

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2021-09-17
• Device Publish Date: 2021-09-09

On-Brand Devices [DermaCol]

• 00714196303448: 00303E
• 00714196302229: 00302E
• 00714196391322: 00303E
• 00714196391308: 00302E