DermaSyn/Ag

GUDID 10714196510157

DERMARITE INDUSTRIES LLC

Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial

• Primary Device ID: 10714196510157
• NIH Device Record Key: aef8b798-9085-49f0-a257-1499b36260d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DermaSyn/Ag
• Version Model Number: 00510
• Company DUNS: 883925562
• Company Name: DERMARITE INDUSTRIES LLC
• Device Count: 12
• 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	00714196510150 [Unit of Use]
GS1	10714196510157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092826

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

On-Brand Devices [DermaSyn/Ag]

• 10714196510157: 00510
• 00714196392329: 00510