Identity
- Trade Name
- ALPHA OMEGA MICRODRIVE HOLDER FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- instrument Rosa 3.0 instrument Rosa 3.1 Alpha Omega microdrive holder FDA UDI
- Model / Reference
- ROSA-128E FDA UDI
- Description
- instrument Rosa 3.0 instrument Rosa 3.1 Alpha Omega microdrive holder FDA UDI
Identifiers
- Catalog Number
- ROSAS00319 FDA UDI
- Primary DI / UDI-DI
- 03760244031181 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Multi-purpose stereotactic surgery system 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Neurological stereotactic surgery systemMulti-purpose stereotactic surgery system
Alpha Omega Microdrive Holder by Medtech Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-purpose stereotactic surgery system.
- TRIALTIS Spine System — MEDOS INTERNATIONAL SARL · Class IIa
- Mo¨ller® — MEDTRONIC NAVIGATION, INC. · Class II
- StealthStation® S7® — MEDTRONIC NAVIGATION, INC. · Class II
- NIM-Spine — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- UNIVERSAL NAVIGATION VIPER SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
- NAVIGATION ENABLED INSTRUMENTS — MEDOS INTERNATIONAL SARL · Class IIa
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC. · Class II
- Stealth Station® S7™ — MEDTRONIC NAVIGATION, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtech Llc
Sources (1)
- FDA UDI cefd9489-e4af-4a20-9ded-11ca0b70cb47 35 fields · synced Jun 8, 2026