DermaCol 100 Sheet

GUDID 00714196033215

DERMARITE INDUSTRIES LLC

Collagen wound matrix dressing

• Primary Device ID: 00714196033215
• NIH Device Record Key: 2d6a3784-e2e7-4cc3-b0f1-6ed150377275
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DermaCol 100 Sheet
• Version Model Number: 003221
• Company DUNS: 883925562
• Company Name: DERMARITE INDUSTRIES LLC
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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	00714196033215 [Primary]
GS1	01714196033214 [Unit of Use]

FDA Product Code

• HGN: Stethoscope, Fetal
• KGN: Dressing, Wound, Collagen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2020-01-27

On-Brand Devices [DermaCol 100 Sheet]

• 00714196033413: 003341
• 00714196033215: 003221
• 00714196391360: 003341
• 00714196391353: 003221