Identity
- Trade Name
- HEMOSTASYL Canules/cannulas EUDAMEDACTEON FDA UDI
- Generic Name
- Dental material injection cannula, single-use FDA UDI
- Device Name
- HEMOSTASYL Canules/cannulas EUDAMEDbox with 40 angled application cannulas for Hemostasyl paste in syringe FDA UDI
- Model / Reference
- 246100 EUDAMEDHemostasyl canula FDA UDI
- Description
- box with 40 angled application cannulas for Hemostasyl paste in syringe FDA UDI
Identifiers
- Catalog Number
- 246100 FDA UDI
- Primary DI / UDI-DI
- 03760243000942 EUDAMEDFDA UDI
- Basic UDI-DI
- 376024300hemocanule28 EUDAMED
- Unit of Use DI
- 03760243009846 EUDAMED
- 510(k) Number
- K082116 FDA UDI
- FDA Product Code
- MVL FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental material injection cannula, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDU FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
HEMOSTASYL Canules/cannulas by Acteon Manufacturing — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 376024300hemocanule28 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Acteon Manufacturing
- EUDAMED SRN
- FR-MF-000007556
Sources (2)
- EUDAMED b33becc4-d27e-4f4a-9fc3-f31128b7a482 61 fields · synced Jun 18, 2026
- FDA UDI 5b43c01e-edc3-4623-bd45-f56137a32791 37 fields · synced May 30, 2026