Cercare Medical Neurosuite with Capillary Function

GUDID 05745000308019

Cercare Medical A/S

Radiology PACS software
Primary Device ID05745000308019
NIH Device Record Key7c7143e2-47bd-4aa8-8f4c-6f719121ec16
Commercial Distribution StatusIn Commercial Distribution
Brand NameCercare Medical Neurosuite with Capillary Function
Version Model NumberCMN with Capillary Function (MR)
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
GS105745000308019 [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 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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