Identity
- Trade Name
- Sterile electrode's cable FDA UDI
- Generic Name
- Depth electrode FDA UDI
- Model / Reference
- Sterile Neuro Omega AlphaProbe electrode's cable 10 CH FDA UDI
Identifiers
- Catalog Number
- STR-000664-21 FDA UDI
- Primary DI / UDI-DI
- 07290014954953 FDA UDI
- 510(k) Number
- K120098 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Depth electrode
Sterile electrode's cable by Alpha Omega Engineering Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Depth electrode.
- DEPTHALON® — Pmt Corp. · Class II
- DEPTHALON® — Pmt Corp. · Class II
- microTargeting™ Electrode — FHC, INC. · Class II
- DEPTHALON® — Pmt Corp. · Class II
- Macro Depth Electrode — Ad-Tech Medical Instrument Corp. · Class II
- DEPTHALON® — Pmt Corp. · Class II
- DEPTHALON® — Pmt Corp. · Class II
- Spencer Probe Depth Electrode — Ad-Tech Medical Instrument Corp. · Class II
Cleared under the same submission
K120098 also covers:
- Cannula — Alpha Omega Engineering Corp.
- Cannula — Alpha Omega Engineering Corp.
- Cannula — Alpha Omega Engineering Corp.
- Cannula — Alpha Omega Engineering Corp.
- Cannula — Alpha Omega Engineering Corp.
- Cannula — Alpha Omega Engineering Corp.
- Cannula — Alpha Omega Engineering Corp.
- NeuroNav Headstage cable — Alpha Omega Engineering Corp.
- NeuroNav Headstage cable - Autoclavable — Alpha Omega Engineering Corp.
- NeuroNav Input Cable — Alpha Omega Engineering Corp.
- NeuroNav Input Cable — Alpha Omega Engineering Corp.
- NeuroNav Input Cable — 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 252ce7d6-5305-4a5e-9526-0ae860211103 35 fields · synced Jun 1, 2026