Tracking Array for Brainpath

GUDID 00670082000030

Synaptive Medical Inc

Neurological stereotactic surgery system
Primary Device ID00670082000030
NIH Device Record Key962e7d8a-14f0-45a8-99c1-b48d6b67013a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTracking Array for Brainpath
Version Model NumberSYN-0015
Company DUNS203061833
Company NameSynaptive Medical Inc
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100670082000030 [Primary]
GS110670082000037 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by Synaptive Medical Inc

00670082000252 - Multi-Tool Calibration Device2025-06-23
00670082000269 - Short Pointer2025-06-23
00670082000351 - Sterilizable Storage Tray2025-06-23
00670082000467 - Modus V2025-06-23 Robotic Digital Microscope
00670082000474 - Modus V2025-06-23 Robotic Digital Microscope
00670082000504 - Modus Nav Software2025-06-23
00670082000528 - Modus Nav Operator Cart2025-06-23
00670082000535 - Long Pointer2025-06-23

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