Identity
- Trade Name
- sEEG DEPTHALON® FDA UDI
- Generic Name
- Depth electrode FDA UDI
- Device Name
- SEEG, 8 CONTACT, 2MM CONTACT, 37MM RECORDING LENGTH, MINI CONNECTOR, 0.8MM THICK FDA UDI
- Model / Reference
- 2102-08-187 FDA UDI
- Description
- SEEG, 8 CONTACT, 2MM CONTACT, 37MM RECORDING LENGTH, MINI CONNECTOR, 0.8MM THICK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00650551004103 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Depth electrode
sEEG DEPTHALON® by Pmt Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Depth electrode.
- NexDrive Electrode Holder — Alpha Omega Engineering Corp. · Class II
- microTargeting™ Electrode — FHC, INC. · Class II
- Macro Depth Electrode — Ad-Tech Medical Instrument Corp. · Class II
- Spencer Probe Depth Electrode — Ad-Tech Medical Instrument Corp. · Class II
- Spencer Probe Depth Electrode — Ad-Tech Medical Instrument Corp. · Class II
- Foramen Ovale Depth Electrode — Ad-Tech Medical Instrument Corp. · Class II
- OneRF Ablation System — NEUROONE MEDICAL TECHNOLOGIES CORP. · Class II
- NeuroSmart MER Headstage — Alpha Omega Engineering Corp. · Class II
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
- Pmt Corp.
Sources (1)
- FDA UDI 6c913ca8-590a-4640-8782-af9c443fe4ea 33 fields · synced May 31, 2026