Mobirex i9

GUDID 04540217069279

SHIMADZU CORPORATION

Mobile basic diagnostic x-ray system, digital
Primary Device ID04540217069279
NIH Device Record Key40b35e02-77d3-4d17-bd1a-8433b981128d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMobirex i9
Version Model Number566-20000-36
Company DUNS690558747
Company NameSHIMADZU 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104540217069279 [Primary]

FDA Product Code

IZLSystem, X-Ray, Mobile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-05-28
Device Publish Date2022-12-16

On-Brand Devices [Mobirex i9]

04540217064991566-20000-26
04540217069279566-20000-36

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