FDA UDI
In Commercial Distribution
🇺🇸 United States
NeuroNav with NeuroFortis Drive
DI: 27290016450044
·
Model: NeuroNav with NeuroFortis Drive
·
ALPHA OMEGA ENGINEERING CO. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NeuroNav with NeuroFortis Drive
- Primary DI
- 27290016450044
- Version / Model
- NeuroNav with NeuroFortis Drive
- Catalog Number
- NNW-006010-55
- Company Name
- ALPHA OMEGA ENGINEERING CO. LTD.
- Labeler DUNS
- 531856466
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-20
- Public Version
- 3
- Public Version Date
- 2019-11-22
- Public Version Status
- Update
- Public Device Record Key
- 9a04ead7-4a67-4b74-ba28-cc7ce46b9d4a
Device Description
NeuroNav system with NeuroFortis Drive : NeurFortis Drive requires sterilization before use.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Hydrogen Peroxide
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 | 27290016450044 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172042 | 000 |