Identity
- Trade Name
- PMT® CORPORATION - SPHENOIDAL FDA UDI
- Generic Name
- Depth electrode FDA UDI
- Device Name
- PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED FDA UDI
- Model / Reference
- 2102-31-03 FDA UDI
- Description
- PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED FDA UDI
Identifiers
- Catalog Number
- 2102-31-03 FDA UDI
- Primary DI / UDI-DI
- 10650551092824 FDA UDI
- 510(k) Number
- K033730 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
Dimensions & Sizes
- Size
- Length — 30 Centimeter FDA UDINeedle Gauge — 21 Gauge FDA UDI
Category: Depth electrode
Pmt® Corporation - Sphenoidal 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
Cleared under the same submission
K033730 also covers:
- PMT® CORPORATION - SPHENOIDAL — Pmt Corp.
- PMT® CORPORATION - SPHENOIDAL — Pmt Corp.
- PMT® CORPORATION - SPHENOIDAL — Pmt Corp.
- PMT® CORPORATION - SPHENOIDAL — Pmt Corp.
- PMT® CORPORATION - SPHENOIDAL — Pmt Corp.
- PMT® CORPORATION - SPHENOIDAL — Pmt Corp.
- PMT® CORPORATION - SPHENOIDAL — Pmt Corp.
- PMT® CORPORATION - SPHENOIDAL — Pmt Corp.
- PMT® CORPORATION - SPHENOIDAL — Pmt Corp.
- PMT® CORPORATION - SPHENOIDAL — Pmt Corp.
- PMT® CORPORATION - SPHENOIDAL — Pmt Corp.
- PMT® CORPORATION - SPHENOIDAL — Pmt 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
- Pmt Corp.
Sources (1)
- FDA UDI 719fa8da-6c07-4f32-a17c-f3a68b85d2c5 38 fields · synced May 30, 2026