Altrazeal Transforming Powder Dressing

GUDID 00860000495097

Altrazeal Transforming Powder Dressing (sterile wound dresing) 0.20g configuration.

Altrazeal Life Sciences Inc.

Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 00860000495097
• NIH Device Record Key: c34f9cbd-d1c1-43e5-ac0b-0c190e8422b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Altrazeal Transforming Powder Dressing
• Version Model Number: 11120-1
• Company DUNS: 624087974
• Company Name: Altrazeal Life Sciences Inc.
• Device Count: 1
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000495097 [Primary]

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: 2025-08-15
• Device Publish Date: 2025-08-07