FDA UDI
In Commercial Distribution
🇺🇸 United States
ACCUNAV® DEPTHALON®
DI: 00650551003465
·
Model: 2102-10-121
·
PMT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACCUNAV® DEPTHALON®
- Primary DI
- 00650551003465
- Version / Model
- 2102-10-121
- Company Name
- PMT CORPORATION
- Labeler DUNS
- 039576871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-15
- Public Version
- 1
- Public Version Date
- 2025-03-24
- Public Version Status
- New
- Public Device Record Key
- 4ee846cd-6521-43c4-8f5b-31596fed0b20
Device Description
ACCUNAV, DEPTH ELECTRODE, 1.8mm DIAMETER, 10 PLATINUM CONTACTS, 2mm CONTACTS, 92mm RECORDING LENGTH, MINI CONNECTOR
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GZL | Electrode, Depth | Neurology | 882.1330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32556 | Depth electrode | An electrical conductor intended to be temporarily placed (< 30 days) beneath the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a fine, flexible plastic device attached to wires that carry currents from deep and superficial brain structures. The wires are connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. The implant is particularly helpful in determining site of origin in temporal and frontal lobe epilepsy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00650551003465 | GS1 |