Identity
- Trade Name
- LEKSELL FRAME ADAPTOR FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- LEKSELL FRAME ADAPTOR instrument Rosa 3.0 instrument Rosa 3.1 Mechanical adaptor to connect the support arm to the leksell stereotactic frame, supplied with 8 mm hexagonal key FDA UDI
- Model / Reference
- ROSA3-176C FDA UDI
- Description
- LEKSELL FRAME ADAPTOR instrument Rosa 3.0 instrument Rosa 3.1 Mechanical adaptor to connect the support arm to the leksell stereotactic frame, supplied with 8 mm hexagonal key FDA UDI
Identifiers
- Catalog Number
- ROSAS00348 FDA UDI
- Primary DI / UDI-DI
- 03760244031396 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
Category: Neurological stereotactic surgery systemMulti-purpose stereotactic surgery system
Leksell Frame Adaptor by Medtech Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Medtech Llc
Sources (1)
- FDA UDI 2a71ff08-1d48-4c23-9bb2-7e1361f34bc1 34 fields · synced Jun 6, 2026