Identity
- Trade Name
- ACCUNAV® FDA UDI
- Generic Name
- Depth electrode FDA UDI
- Device Name
- DEPTH ELECTRODE, PLATINUM, 8 CONTACT (2MM), INLINE CONNECTOR FDA UDI
- Model / Reference
- 2102-08-120 FDA UDI
- Description
- DEPTH ELECTRODE, PLATINUM, 8 CONTACT (2MM), INLINE CONNECTOR FDA UDI
Identifiers
- Catalog Number
- 2102-08-120 FDA UDI
- Primary DI / UDI-DI
- 00650551040699 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
- Outer Diameter — 1.8 Millimeter FDA UDI
Category: Depth electrode
A medical device used for temporary placement of an electrical conductor beneath the surface of the brain to stimulate or record brain activity. It is particularly helpful in determining the site of origin in temporal and frontal lobe epilepsy.
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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 d6964fb8-4157-438a-9448-ea6875c52d56 37 fields · synced Jul 11, 2026