Axiostat Patch

GUDID 08600087686290

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.

AXIO BIOSOLUTIONS PRIVATE LIMITED

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• Primary Device ID: 08600087686290
• NIH Device Record Key: 569d593f-900c-4c56-b698-92fa81ef46a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axiostat Patch
• Version Model Number: V35
• Company DUNS: 877003031
• Company Name: AXIO BIOSOLUTIONS PRIVATE LIMITED
• 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	08600087686290 [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: 2023-08-24
• Device Publish Date: 2023-08-16

Devices Manufactured by AXIO BIOSOLUTIONS PRIVATE LIMITED

• 08600087686122 - Axiostat Gauze: 2023-08-24 Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleedin
• 08600087686290 - Axiostat Patch: 2023-08-24Axiostat 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.
• 08600087686290 - Axiostat Patch: 2023-08-24 Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dres
• 08600087686368 - Axiostat Gauze: 2023-08-24 Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleedin
• 08600087686504 - Axiostat Gauze: 2023-08-24 Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleedin
• 08600087686740 - Axiostat Gauze: 2023-08-24 Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleedin