DermaSyn

GUDID 00714196112460

DERMARITE INDUSTRIES LLC

Wound hydrogel dressing, non-sterile

• Primary Device ID: 00714196112460
• NIH Device Record Key: 742859fc-a7b5-41a7-bf81-e61f66c9038d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DermaSyn
• Version Model Number: 11246
• Company DUNS: 883925562
• Company Name: DERMARITE INDUSTRIES LLC
• Device Count: 20
• 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	00714196112460 [Primary]
GS1	10714196112467 [Unit of Use]

FDA Product Code

• NAE: Dressing, Wound, Hydrogel Without Drug And/Or Biologic

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: 2020-09-09
• Device Publish Date: 2020-09-01

On-Brand Devices [DermaSyn]

• 00714196248084: 00248
• 00714196247032: 00247
• 00714196112460: 11246
• 00714196112453: 11245
• 71419624712486: 00247