InfiMed Digital Imaging System, i5, DR, Digital Receptor

GUDID 00854344007047

VAREX IMAGING CORPORATION

X-ray system computer, diagnostic, general-purpose
Primary Device ID00854344007047
NIH Device Record Key935ddeb4-6288-445b-b7c0-00fa019dc5af
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfiMed Digital Imaging System, i5, DR, Digital Receptor
Version Model Numberi5 DR
Company DUNS080506857
Company NameVAREX IMAGING CORPORATION
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 Numbertrue
Manufacturing Datetrue
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
GS100854344007047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWBInterventional Fluoroscopic X-Ray System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-24

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