Identity
- Trade Name
- Axiostat Patch FDA UDI
- Generic Name
- Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- V35 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860008768629 FDA UDI
- 510(k) Number
- K202830 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
Classification
- Device Class
- U 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
No
FDA UDI
Category: Chitosan haemostatic agent, professional, non-bioabsorbable
Axiostat Patch by Advamedica, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chitosan haemostatic agent, professional, non-bioabsorbable.
- Celox Rapid Z-Fold Gauze — Medtrade Products , Ltd. · U
- HemCon ChitoGauze XR2 Pro, 3in x 4yd — Tricol Biomedical, INC. · U
- QUIKCLOT — TELEFLEX INCORPORATED · U
- CELOX Gauze — Medtrade Products , Ltd. · U
- HemCon® OneStop™ Bandage, 2in x 2in — Tricol Biomedical, INC. · U
- PosiSep X2 0.8" x 2.3" — Hemostasis, LLC · Class I
- CELOX Vascular — Medtrade Products , Ltd. · U
- GuardaCare® PRO, 4in x 4in, 8ply — Tricol Biomedical, INC. · U
Cleared under the same submission
K202830 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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advamedica, Inc.
Sources (1)
- FDA UDI 6f8da637-bc05-4634-9742-c69c04cde54a 34 fields · synced May 30, 2026