BrightMatter Plan SYN-0866

GUDID 00670082000412

Synaptive Medical Inc

Radiology PACS software Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software
Primary Device ID00670082000412
NIH Device Record Key6c5b7a27-7277-420e-a375-4f195b1a9cc9
Commercial Distribution Discontinuation2019-08-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBrightMatter Plan
Version Model Number1.6
Catalog NumberSYN-0866
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100670082000412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-08-07
Device Publish Date2018-09-28

On-Brand Devices [BrightMatter Plan]

006700820004121.6
006700820003681.5
006700820001601.4
006700820000851.3
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