Localite TMS Navigator TS 10205

GUDID G076A010205AM3N40

LOCALITE GmbH

Stereotactic neuronavigation/planning system
Primary Device IDG076A010205AM3N40
NIH Device Record Key0f1eb09b-c052-4a02-b52b-2a55033be709
Commercial Distribution StatusIn Commercial Distribution
Brand NameLocalite TMS Navigator TS
Version Model NumberTMS Navigator SW MR-Based
Catalog Number10205
Company DUNS315271657
Company NameLOCALITE GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG076A010205AM3N40 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-13
Device Publish Date2023-12-05

On-Brand Devices [Localite TMS Navigator TS]

G076A900587A0System Cart
G076A200001A0Pivot-mounted Arm for Camera Cart/Wall Mount
G076A014227A0Adhesive Base for Tracker
G076A014226A0Tracker Bracket, 38 mm
G076A014222A0Tracker Bracket, 29 mm
G076A014221A0Tracker Bracket, 25 mm
G076A012355A0Adhesive Pads, square-cut (90 Pcs.)
G076A012354A0Adhesive Pads, round (250 pcs.)
G076A010235AM3N30MagVenture Stimulator Control (Software Module)
G076A010233AM3N30Functional Data (Software Module)
G076A010232AM3N30Stimulation Response Export (Software Module)
G076A010226AM3N30MR-Based (Image Data Component)
G076A010225AM3N30MR-Less (Image Data Component)
G076A010206AM3N30TMS Navigator SW MR-Less
G076A010205AM3N30TMS Navigator SW MR-Based
G076A010021A0Adapter Box
G076A003222A0Tracker Top, Geo. 2
G076A003221A0Tracker Top, Geo. 1
G076A002209A0Adhesive Head Tracker
G076A002097A0Calibration Pins, 25/10
G076A002009A0Pointer ST
G076A002006A0Calibration Plate
G076A001216A0Camera cart for Vicra
G076A001212A0Camera cart for Spectra/Vega
G076A001164A0Foot switch, 3 Pedals
G076A001111A0Pointer
G076A900649A0Camera Cart for Vega (LAN Cabling)
G076A010235AM3N40MagVenture Stimulator Control (Software Module)
G076A010233AM3N40Functional Data (Software Module)
G076A010232AM3N40Stimulation Response Export (Software Module)
G076A010226AM3N40MR-Based (Image Data Component)
G076A010225AM3N40MR-Less (Image Data Component)
G076A010206AM3N40TMS Navigator SW MR-Less
G076A010205AM3N40TMS Navigator SW MR-Based
G076A001216B0Camera Cart for Vicra/Lyra

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.