Ax-Surgi Surgical Hemostat

GUDID 00860012016648

Ax-Surgi Surgical Hemostat which is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It is intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries.

Advamedica Inc.

Chitosan haemostatic agent, professional

• Primary Device ID: 00860012016648
• NIH Device Record Key: abf2cd29-af50-40e3-af26-d604d58cfcae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ax-Surgi Surgical Hemostat
• Version Model Number: SH1006
• 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: true
• 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	00860012016648 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213198

FDA Product Code

• POD: Temporary, Internal Use Hemostatic

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: 2024-11-05
• Device Publish Date: 2024-10-28

On-Brand Devices [Ax-Surgi Surgical Hemostat ]

• 00860012016631: Ax-Surgi Surgical Hemostat which is indicated for temporary control of internal organ space blee
• 00860012016624: Ax-Surgi Surgical Hemostat which is indicated for temporary control of internal organ space blee
• 00860012016648: Ax-Surgi Surgical Hemostat which is indicated for temporary control of internal organ space blee