Identity
- Trade Name
- sEEG DEPTHALON® FDA UDI
- Generic Name
- Depth electrode FDA UDI
- Device Name
- PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, 0.8MM OD, 2MM CONTACT LENGTH, 100MM RECORDING DEPTH, FDA UDI
- Model / Reference
- 2102-16-192 FDA UDI
- Description
- PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, 0.8MM OD, 2MM CONTACT LENGTH, 100MM RECORDING DEPTH, FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00650551004837 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
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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 |
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Manufacturer
- Manufacturer
- Pmt Corp.
Sources (1)
- FDA UDI 5f52d6e2-601f-4bcc-9cec-5d715ef4a9d8 33 fields · synced May 30, 2026