Identity
- Trade Name
- Libenger ZD frame Mechanical Set Kit FDA UDI
- Generic Name
- Depth electrode FDA UDI
- Model / Reference
- Libenger ZD frame Mechanical Set KIT FDA UDI
Identifiers
- Catalog Number
- 700-020847-00 FDA UDI
- Primary DI / UDI-DI
- 27290016450990 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
No
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
Category: Depth electrode
Libenger ZD frame Mechanical Set Kit by Alpha Omega Engineering Corp. — Class II — FDA UDI — listed in FDA GUDID — 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 RM frame Mechanical Set KIT — 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.
- NexDrive Electrode Holder — Alpha Omega Engineering Corp.
- NexDrive Electrode Holder - Pack of 2 — Alpha Omega Engineering Corp.
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
- Alpha Omega Engineering Corp.
Sources (1)
- FDA UDI 0a882f1f-e85d-4c59-8ddd-592d7420f9d5 34 fields · synced May 30, 2026