← Back to catalogue
Apex Femoral Nail PF Left Ø 11.5 x 360mm
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref F01-115360
by OrthoXel DAC
Identity
- Trade Name
- Apex Femoral Nail PF Left Ø 11.5 x 360mm EUDAMEDApex FDA UDI
- Generic Name
- Femur intramedullary nail FDA UDI
- Device Name
- Apex Femoral Nail PF Left Ø 11.5 x 360mm EUDAMEDFDA UDI
- Model / Reference
- F01-115360 EUDAMEDFDA UDI
- Description
- Apex Femoral Nail PF Left Ø 11.5 x 360mm FDA UDI
Identifiers
- Catalog Number
- F01-115360 FDA UDI
- Primary DI / UDI-DI
- 05391529581305 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529581305 EUDAMED
- FDA Product Code
- HSB FDA UDI
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS EUDAMED
- GMDN Term
- Femur intramedullary nail FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Apex Femoral Nail PF Left Ø 11.5 x 360mm by OrthoXel DAC — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Manufacturer's product page: Apex Femoral Antegrade Nailing System
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05391529581305 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
Sources (2)
- EUDAMED 0c0d83bc-583e-4387-ab1a-447f2fe47778 61 fields · synced Oct 7, 2026
- FDA UDI 158e13f8-23ec-457c-bc0d-e55a83d1989c 37 fields · synced May 30, 2026