Mobirex i9

GUDID 04540217064991

SHIMADZU CORPORATION

Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital
Primary Device ID04540217064991
NIH Device Record Key6d6d471c-a887-4052-a5af-4c11aee7eabe
Commercial Distribution StatusIn Commercial Distribution
Brand NameMobirex i9
Version Model Number566-20000-26
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
GS104540217064991 [Primary]

FDA Product Code

IZLSystem, X-Ray, Mobile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-22
Device Publish Date2022-06-14

Devices Manufactured by SHIMADZU CORPORATION

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04540217071357 - RADspeed Pro2024-04-09
04540217071364 - RADspeed Pro2024-04-09
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04540217071388 - RADspeed Pro2024-04-09

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