AccessGUDID - DEVICE: Localite TMS Navigator TS (G076A010233AM3N30)

GUDID

Device Identifier (DI) Information

Brand Name: Localite TMS Navigator TS
Version or Model: Functional Data (Software Module)
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 10233
Company Name: LOCALITE GmbH

Primary DI Number: G076A010233AM3N30
Issuing Agency: HIBCC
Commercial Distribution End Date: October 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 315271657 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAW	Neurological Stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223577	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eb4cc5c3-4f5b-43c7-88fb-332c7fa48345
Public Version Date: December 06, 2023
Public Version Number: 2
DI Record Publish Date: July 05, 2023