Identity
- Trade Name
- Leibinger RM frame Mechanical Set KIT FDA UDI
- Generic Name
- Depth electrode FDA UDI
- Model / Reference
- Long Bengun FDA UDI
Identifiers
- Catalog Number
- 700-020874-00 FDA UDI
- Primary DI / UDI-DI
- 27290114064112 FDA UDI
- 510(k) Number
- K051830 FDA UDI
- FDA Product Code
- GZL FDA UDI
- GMDN Term
- Depth electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1330 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
Dry Heat Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Depth electrode
Leibinger RM frame Mechanical Set KIT by Alpha Omega Engineering Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K051830 also covers:
- Bengun Adapter — Alpha Omega Engineering Corp.
- Bengun W/O Screws — Alpha Omega Engineering Corp.
- CRW Non-XY frame Mechanical Set KIT — Alpha Omega Engineering Corp.
- CRW Non-XY frame Mechanical Set KIT — Alpha Omega Engineering Corp.
- Frame adapter thumb screw - Pack of 3 — Alpha Omega Engineering Corp.
- Leibinger ZD frame Mechanical Set KIT — Alpha Omega Engineering Corp.
- Leksell Non-XY frame Mechanical Set KIT — Alpha Omega Engineering Corp.
- Leksell Non-XY frame Mechanical Set Kit — Alpha Omega Engineering Corp.
- Libenger RM frame Mechanical Set KIT — Alpha Omega Engineering Corp.
- Libenger ZD frame Mechanical Set Kit — Alpha Omega Engineering Corp.
- NexDrive Electrode Holder — Alpha Omega Engineering Corp.
- NexDrive Electrode Holder - Pack of 2 — Alpha Omega Engineering Corp.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- Alpha Omega Engineering Corp.
Sources (2)
- FDA UDI 12f309cd-0215-4fe3-ae46-f9913499ec5e 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026