Identity
- Trade Name
- UNIVERSAL NAVIGATION VIPER FDA UDI
- Generic Name
- Stereotactic surgery system probe, reusable FDA UDI
- Device Name
- UNIVERSAL NAVIGATION VIPER SYSTEM SAI MIS POLYAXIAL DRIVER SHAFT, CANNULATED FDA UDI
- Model / Reference
- 2797-04-401N FDA UDI
- Description
- UNIVERSAL NAVIGATION VIPER SYSTEM SAI MIS POLYAXIAL DRIVER SHAFT, CANNULATED FDA UDI
Identifiers
- Catalog Number
- 279704401N FDA UDI
- Primary DI / UDI-DI
- 10705034531748 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Stereotactic surgery system probe, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Stereotactic surgery system probe, reusable
Universal Navigation Viper by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K120867 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medos International Sàrl
Sources (1)
- FDA UDI 5d18454b-5779-40f8-bc1f-4fec0499db3f 36 fields · synced Jun 6, 2026