FDA UDI
In Commercial Distribution
🇺🇸 United States
Nexstim Head Tracker Tape
DI: 06430063200200
·
Model: NX87246
·
Nexstim Oyj
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nexstim Head Tracker Tape
- Primary DI
- 06430063200200
- Version / Model
- NX87246
- Catalog Number
- NX147609
- Company Name
- Nexstim Oyj
- Labeler DUNS
- 369521989
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-17
- Public Version
- 1
- Public Version Date
- 2025-10-27
- Public Version Status
- New
- Public Device Record Key
- 72d0116f-75a9-4e54-af4a-b3fae85876a0
Device Description
Nexstim Head Tracker Tape (box of 200). Part list nr NX144903.
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
- No
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | Neurology | 882.1870 | 2 |
| HAW | Neurological Stereotaxic Instrument | Neurology | 882.4560 | 2 |
| IKN | Electromyograph, Diagnostic | Physical Medicine | 890.1375 | 2 |
| OBP | Transcranial Magnetic Stimulator | Neurology | 882.5805 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56641 | Stereotactic neuronavigation/planning system | A mobile assembly of mains electricity (AC-powered) electronic and optical devices designed to receive and analyse patient magnetic resonance imaging (MRI) images and position landmarks manually or automatically on these images, then register the images by the mean of a three-dimensional (3-D) optical positioning system (frameless stereotactic neuronavigation) to provide real-time relative positioning for the treatment probes and instruments. It is typically used by healthcare providers in psychiatry, neuropsychiatry, and neurology for preoperative planning, in particular for consecutive image-guided transcranial magnetic stimulation (TMS) treatment sessions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06430063200200 | GS1 |
Customer Contacts
- Phone
- +35892727170
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182700 | 000 |