FDA UDI
In Commercial Distribution
🇺🇸 United States
Localite TMS Navigator TS
DI: G076A012355A1
·
Model: Adhesive Pads, square-cut (90 Pcs.)
·
LOCALITE GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
90
Basic Information
- Brand Name
- Localite TMS Navigator TS
- Primary DI
- G076A012355A1
- Version / Model
- Adhesive Pads, square-cut (90 Pcs.)
- Catalog Number
- 12355
- Company Name
- LOCALITE GmbH
- Labeler DUNS
- 315271657
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 90
- Record Status
- Published
- Publish Date
- 2023-07-05
- Public Version
- 1
- Public Version Date
- 2023-07-13
- Public Version Status
- New
- Public Device Record Key
- 3ed2a88b-96e3-49e3-ae65-45b71ebbc7bf
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- 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 |
|---|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | Neurology | 882.4560 | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | G076A012355A0 | HIBCC | ||||
| Primary | G076A012355A1 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223577 | 000 |