FDA UDI Not in Commercial Distribution 🇺🇸 United States

Localite TMS Navigator TS

DI: G076A010232AM3N30 · Model: Stimulation Response Export (Software Module) · LOCALITE GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Localite TMS Navigator TS
Primary DI
G076A010232AM3N30
Version / Model
Stimulation Response Export (Software Module)
Catalog Number
10232
Company Name
LOCALITE GmbH
Labeler DUNS
315271657
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-07-05
Public Version
2
Public Version Date
2023-12-06
Public Version Status
Update
Public Device Record Key
39ab24d5-5e6b-40cc-9679-a47a6813e4db
Distribution End Date
2023-10-30

Device Characteristics

Single Use
No
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
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
HAW Neurological Stereotaxic Instrument

GMDN Terms

Code Name
56641 Stereotactic neuronavigation/planning system

Identifiers

Type ID
Primary G076A010232AM3N30

Premarket Submissions

Submission Number Supplement Number
K223577 000