Ashvins variant Ashvins Diagnostic Workstation

GUDID 04260648620077

MedicalCommunications GmbH

Radiology picture archiving and communication system workstation
Primary Device ID04260648620077
NIH Device Record Key5eb8d8d8-2963-4a6d-8e9d-ec69ff0d33a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAshvins variant Ashvins Diagnostic Workstation
Version Model Number2023 (Build 2167)
Company DUNS314721366
Company NameMedicalCommunications GmbH
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
GS104260648620077 [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 Date2024-07-17
Device Publish Date2024-07-09

On-Brand Devices [Ashvins variant Ashvins Diagnostic Workstation]

042606486200842023 (Build 2088)
042606486200772023 (Build 2167)

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