Identity
- Trade Name
- Ax-Surgi Surgical Hemostat FDA UDI
- Generic Name
- Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SH1004 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860012016631 FDA UDI
- 510(k) Number
- K213198 FDA UDI
- FDA Product Code
- POD FDA UDI
- GMDN Term
- Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4454 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Chitosan haemostatic agent, professional, non-bioabsorbable
Ax-Surgi Surgical Hemostat by Advamedica, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K213198 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Advamedica, Inc.
Sources (1)
- FDA UDI 301d0c1f-0b9d-4144-8e35-dc323798c85f 34 fields · synced May 30, 2026