Navigation Enabled Instruments
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- NAVIGATION ENABLED INSTRUMENTS EUDAMEDEXPEDIUM VERSE FDA UDI
- Generic Name
- Orthopaedic implantation sleeve, reusable FDA UDI
- Device Name
- Navigation Enabled Driver Shaft Sleeve Awl Tip Tap for the Thoracic-Lumbar-Sacral Spine EUDAMEDEXPEDIUM VERSE SLEEVE NAVIGATION ENABLED INSTRUMENTS FDA UDI
- Model / Reference
- Navigation Enabled Instruments for the Thoracic-Lumbar-Sacral Spine EUDAMED3010-19-041 EUDAMEDFDA UDI
- Description
- EXPEDIUM VERSE SLEEVE NAVIGATION ENABLED INSTRUMENTS FDA UDI
Identifiers
- Catalog Number
- 301019041 FDA UDI
- Primary DI / UDI-DI
- 10705034561677 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a002355Z EUDAMED
- Direct Marketing DI
- 10705034561677 EUDAMED
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic implantation sleeve, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Belgium 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
Yes
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Multi-purpose stereotactic surgery system
Navigation Enabled Instruments by Medos International Sarl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705034a002355Z | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED 29f9cc89-3e93-4e76-a706-221086a71f6d 61 fields · synced Jul 20, 2026
- FDA UDI 51bcb7da-87fb-42f2-9af3-07309fdc48ad 35 fields · synced May 30, 2026