XeroBurn Sterile Burn Dressings, 4" x 4"

GUDID 00810180840507

STERILE-R

Dynarex Corporation

Synthetic polymer burn dressing, gel-coated

• Primary Device ID: 00810180840507
• NIH Device Record Key: 84869ff8-b290-4b96-8b9d-0c636a6b5861
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XeroBurn Sterile Burn Dressings, 4" x 4"
• Version Model Number: 1295BULK
• Company DUNS: 008124539
• Company Name: Dynarex Corporation
• Device Count: 100
• 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: true
• 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	00810180840507 [Unit of Use]
GS1	00840117332898 [Primary]

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-10-29
• Device Publish Date: 2024-03-11

On-Brand Devices [ XeroBurn Sterile Burn Dressings, 4" x 4"]

• 08401173328984: STERILE-R
• 00810180840507: STERILE-R