Viper Prime
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- VIPER PRIME EUDAMEDFDA UDI
- Generic Name
- Stereotactic surgery system probe, reusable FDA UDI
- Device Name
- VIPER PRIME Navigated Inserter Drive Tube, Shaft, Adaptors, and Stylet EUDAMEDVIPER PRIME NAV SHAFT ASSY FDA UDI
- Model / Reference
- VIPER PRIME Navigated Inserter Instruments EUDAMED286750131N EUDAMEDFDA UDI
- Description
- VIPER PRIME NAV SHAFT ASSY FDA UDI
Identifiers
- Catalog Number
- 286750131N FDA UDI
- Primary DI / UDI-DI
- 10705034507781 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a0014763 EUDAMED
- Direct Marketing DI
- 10705034507781 EUDAMED
- 510(k) Number
- K170937 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Stereotactic surgery system probe, 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
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Multi-purpose stereotactic surgery system
Viper Prime by Medos International Sarl — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170937 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0705034a0014763 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (3)
- EUDAMED b19ff35a-c9ac-440e-9d1d-15068b557f17 85 fields · synced Jun 18, 2026
- FDA UDI 1e3bd860-2e84-491e-abf4-60727dfcfdc8 36 fields · synced May 30, 2026
- FDA 510(k) K170937 1 fields · synced May 18, 2026