Axiostat Patch

GUDID 00860008768629

Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing for patients and for the rapid control of moderate to severe bleeding. The dressing is indicated for the following wounds: lacerations, abrasions, surgical debridement sites, skin surface puncture sites, vascular procedure sites and sites involving percutaneous catheters, tubes and pins.

Advamedica Inc.

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• Primary Device ID: 00860008768629
• NIH Device Record Key: 6f8da637-bc05-4634-9742-c69c04cde54a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axiostat Patch
• Version Model Number: V35
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008768629 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202830

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 Patch ]

• 00860008768629: Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to b
• 00860008768605: Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to b