Identity
- Trade Name
- Leksell Vantage Stereotactic System FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- ARC SLIDE RIGHT FDA UDI
- Model / Reference
- 1040125 FDA UDI
- Description
- ARC SLIDE RIGHT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07340201501948 FDA UDI
- 510(k) Number
- K190887 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
- 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Neurological stereotactic surgery system
Leksell Vantage Stereotactic System by Elekta Solutions AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Neurological stereotactic surgery system.
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- Leksell Stereotactic System — Elekta Instrument AB · Class II
Cleared under the same submission
K190887 also covers:
- Leksell Vantage Stereotactic System — Elekta Instrument AB
- Leksell Vantage Stereotactic System — Elekta Instrument AB
- Leksell Vantage Stereotactic System — Elekta Instrument AB
- Leksell Vantage Stereotactic System — Elekta Instrument AB
- Leksell Vantage Stereotactic System — Elekta Solutions AB
- Leksell Vantage Stereotactic System — Elekta Solutions AB
- Leksell Vantage Stereotactic System — Elekta Solutions AB
- Leksell Vantage Stereotactic System — Elekta Solutions AB
- Leksell Vantage Stereotactic System — Elekta Solutions AB
- Leksell Vantage Stereotactic System — Elekta Solutions AB
- Leksell Vantage Stereotactic System — Elekta Solutions AB
- Leksell Vantage Stereotactic System — Elekta Solutions AB
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 Solutions AB
Sources (1)
- FDA UDI 4f60ad66-3fe0-4dc3-af52-fd14940e6a28 35 fields · synced Jun 1, 2026