Apex Nailing System Opening and Reaming Case
EUDAMEDFDA UDIClass I (EU MDR)
by OrthoXel DAC
Identity
- Trade Name
- Apex Nailing System Opening and Reaming Case EUDAMEDApex FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Apex Nailing System Opening and Reaming Case EUDAMEDFDA UDI
- Model / Reference
- INS-1079 EUDAMEDFDA UDI
- Description
- Apex Nailing System Opening and Reaming Case FDA UDI
Identifiers
- Catalog Number
- INS-1079 FDA UDI
- Primary DI / UDI-DI
- 05391529582890 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529582890 EUDAMED53915295822035V EUDAMED
- Direct Marketing DI
- 05391529582890 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Apex Nailing System Opening and Reaming Case by OrthoXel DAC — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Manufacturer's product page: First Apex Tibial Nail Case in Mainland Europe
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05391529582890 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-05391529582890 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
Sources (3)
- EUDAMED de1e4bff-b75d-4e00-83b2-35f8be332e10 61 fields · synced Jul 24, 2026
- EUDAMED a6888359-e0b7-4c48-875b-feadab3f6ace 61 fields · synced May 19, 2026
- FDA UDI d1dadd51-4a7e-4515-a6ed-3e66157e76f3 36 fields · synced May 30, 2026