Cercare Medical Neurosuite with Capillary Function

GUDID 05745000308118

Cercare Medical Neurosuite with Capillary Function ver. 14

Cercare Medical A/S

Radiological PACS software
Primary Device ID05745000308118
NIH Device Record Key0df962a5-b0e0-478a-863f-7aca79fb53c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCercare Medical Neurosuite with Capillary Function
Version Model Number14
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
GS105745000308064 [Previous]
GS105745000308118 [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 Date2024-05-29
Device Publish Date2024-05-21

On-Brand Devices [Cercare Medical Neurosuite with Capillary Function]

05745000308019CMN with Capillary Function (MR)
057450003080642023-06-01
05745000308118Cercare Medical Neurosuite with Capillary Function ver. 14
05745000308163Cercare Medical Neurosuite with Capillary Function ver. 15

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