BrightMatter Pointer

GUDID 00670082000092

Synaptive Medical Inc

Neurological stereotactic surgery system Neurological stereotactic surgery system
Primary Device ID00670082000092
NIH Device Record Keycc377fa8-c298-4133-a0a6-9aec4206b963
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrightMatter Pointer
Version Model NumberSYN-0642
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100670082000092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00670082000092]

Moist Heat or Steam Sterilization


[00670082000092]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-11-11

Devices Manufactured by Synaptive Medical Inc

00670082000603 - Modus IR2024-04-10 Surgical Exoscope Fluorescence Filter
10670082000495 - Evry2023-10-24
00670082000511 - Modus Plan2023-10-18
00670082000566 - Modus X2023-03-14 Robotic Exoscope
00670082000573 - Modus X2023-03-14 Robotic Exoscope
00670082000580 - Modus Blue2023-03-14 Robotic Exoscope Fluorescence Filter
00670082000085 - BrightMatter Plan2019-08-16
00670082000160 - BrightMatter Plan2019-08-16

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