Neuromate Planning Station Hardware 001.0130

GUDID 03662724000451

RENISHAW MAYFIELD

Neurological stereotactic surgery system
Primary Device ID03662724000451
NIH Device Record Key8fdc30b2-96db-4d90-91f3-f3b189717487
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuromate Planning Station Hardware
Version Model Numberneuroinspire PC - Laptop US
Catalog Number001.0130
Company DUNS277433335
Company NameRENISHAW MAYFIELD
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 Numbertrue
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
GS103662724000451 [Primary]

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 Date2024-03-20
Device Publish Date2024-03-12

On-Brand Devices [Neuromate Planning Station Hardware]

03662724000758PC Cart (Workstation Cart)
03662724000451neuroinspire PC - Laptop US
03662724000444neuroinspire PC - Desktop US

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