DermaGinate/Ag Healogics by DermaRite

GUDID 00714196935137

DERMARITE INDUSTRIES LLC

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 00714196935137
• NIH Device Record Key: 16b21c52-fa2d-44f1-9f6b-381df779d9e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DermaGinate/Ag Healogics by DermaRite
• Version Model Number: 93513
• 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: true
• 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	00714196935137 [Primary]
GS1	01714196935136 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143335

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 [DermaGinate/Ag Healogics by DermaRite]

• 00714196935137: 93513
• 00714196935120: 93512