Ashvins variant HEYEX 2 / HEYEX PACS

GUDID 04260648620060

MedicalCommunications GmbH

Ophthalmology PACS software
Primary Device ID04260648620060
NIH Device Record Key21b14c90-a500-405f-af39-f5f50e62a183
Commercial Distribution StatusIn Commercial Distribution
Brand NameAshvins variant HEYEX 2 / HEYEX PACS
Version Model Number2.6.5 (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
GS104260648620060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NFJSystem, Image Management, Ophthalmic

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 HEYEX 2 / HEYEX PACS]

042606486200152.5
042606486200462.6
042606486200602.6.5 (Build 2167)

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