DermaCol Healogics by Dermarite

GUDID 00714196933126

DERMARITE INDUSTRIES LLC

Biochemically-interactive dressing

• Primary Device ID: 00714196933126
• NIH Device Record Key: 3bcb9988-5a4b-4ea6-a8d1-0ac2e0f3d863
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DermaCol Healogics by Dermarite
• Version Model Number: 93312
• Company DUNS: 883925562
• Company Name: DERMARITE INDUSTRIES LLC
• Device Count: 10
• 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	00714196933126 [Primary]
GS1	01714196933125 [Unit of Use]

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: 2020-02-05
• Device Publish Date: 2020-01-28

On-Brand Devices [DermaCol Healogics by Dermarite]

• 00714196933126: 93312
• 00714196933119: 93311