Identity
- Trade Name
- Leksell Stereotactic System FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- MR-ADAPTER PICKER EDGE FDA UDI
- Model / Reference
- A0420-30 FDA UDI
- Description
- MR-ADAPTER PICKER EDGE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07340048300926 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- Not 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
MR Safe FDA UDI
Leksell Stereotactic System by Elekta Instrument AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Elekta Instrument AB
Sources (1)
- FDA UDI 5164021b-3780-4120-8c84-cf1d3b4ea74c 35 fields · synced May 30, 2026