neuromate neuroinspire software 001.0142

GUDID 03662724000390

RENISHAW MAYFIELD

Neurological stereotactic surgery system
Primary Device ID03662724000390
NIH Device Record Key88ee3a4a-7b46-4b25-b3c0-5458c7c65cd4
Commercial Distribution StatusIn Commercial Distribution
Brand Nameneuromate neuroinspire software
Version Model Numberneuroinspire planning software
Catalog Number001.0142
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 Batchfalse
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
GS103662724000390 [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

Devices Manufactured by RENISHAW MAYFIELD

03662724000390 - neuromate neuroinspire software2024-03-20
03662724000390 - neuromate neuroinspire software2024-03-20
03662724000444 - neuromate planning station hardware2024-03-20
03662724000451 - Neuromate Planning Station Hardware2024-03-20
03662724000482 - neuromate - neuroinspire software2024-03-20
03662724000758 - neuromate planning station hardware2024-03-20
03662724000031 - neuromate tool-holder2022-04-08 The standard tool-holder is universal and features a guide bushing into which standard neurosurgical instruments may be inserted
03662724000055 - neuromate tool guide2022-04-08 Tool adaptor or guide bushing to accommodate various diameters of instruments. Only the diameter of the central hole is adapted.
03662724000079 - neuromate tool guide2022-04-08 Long tool adaptor or guide bushing to accommodate various diameters of instruments. Only the diameter of the central hole is ada

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