Cercare Medical Neurosuite

GUDID 05745000308002

Cercare Medical A/S

Radiology PACS software
Primary Device ID05745000308002
NIH Device Record Key91d885e6-21d0-4c46-8e12-60c856ff39d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCercare Medical Neurosuite
Version Model NumberCercare Medical Neurosuite
Company DUNS305457217
Company NameCercare Medical A/S
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105745000308002 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-12
Device Publish Date2023-05-04

On-Brand Devices [Cercare Medical Neurosuite]

05745000308002Cercare Medical Neurosuite
057450003080572023-06-01
05745000308101Cercare Medical Neurosuite ver. 14
05745000308156Cercare Medical Neurosuite ver. 15

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