Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Non-organic haemostatic agent FDA UDI
- Device Name
- HEMOSTASYL is a paste to be used as a haemostatic dressing with a mechanical action. Kit containing: 2 x 2g syringes of HEMOSTASYL Paste (about 30 uses) and 40 HEMOSTASYL angled application cannulas. Syringe for multiple uses. Application cannulas for single use. FDA UDI
- Model / Reference
- Hemostasyl Kit FDA UDI
- Description
- HEMOSTASYL is a paste to be used as a haemostatic dressing with a mechanical action. Kit containing: 2 x 2g syringes of HEMOSTASYL Paste (about 30 uses) and 40 HEMOSTASYL angled application cannulas. Syringe for multiple uses. Application cannulas for single use. FDA UDI
Identifiers
- Catalog Number
- 246200 FDA UDI
- Primary DI / UDI-DI
- 03760243000959 FDA UDI
- 510(k) Number
- K082116 FDA UDI
- FDA Product Code
- MVL FDA UDI
- GMDN Term
- Non-organic haemostatic agent FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Acteon by Acteon Manufacturing — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Acteon Manufacturing
Sources (1)
- FDA UDI c4f10845-6278-49b2-b5e1-8976c5d89214 38 fields · synced May 31, 2026