Axiostat Gauze

GUDID 00860008768674

Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations. OTC Use - The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.

Advamedica Inc.

Chitosan haemostatic agent, professional

• Primary Device ID: 00860008768674
• NIH Device Record Key: e0ec3d87-0242-427a-8cb8-6c1ece32c741
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axiostat Gauze
• Version Model Number: AG4010
• Company DUNS: 118526617
• Company Name: Advamedica Inc.
• Device Count: 1
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008768674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222909

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: 2023-12-25
• Device Publish Date: 2023-12-16

On-Brand Devices [Axiostat Gauze]

• 00860008768674: Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to co
• 00860008768650: Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to co
• 00860008768636: Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to co
• 00860008768612: Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to co