BRANSIST safire

GUDID 04540217010479

SHIMADZU CORPORATION

Stationary angiographic x-ray system, digital
Primary Device ID04540217010479
NIH Device Record Key34267429-9ab7-4938-8bba-30a17e81eb5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBRANSIST safire
Version Model Number503-67100-28
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 Producttrue
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
GS104540217010479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZISystem, X-Ray, Angiographic

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 Date2016-09-16

Devices Manufactured by SHIMADZU CORPORATION

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04540217071326 - RADspeed Pro2024-04-09
04540217071333 - RADspeed Pro2024-04-09
04540217071340 - RADspeed Pro2024-04-09
04540217071357 - RADspeed Pro2024-04-09
04540217071364 - RADspeed Pro2024-04-09
04540217071371 - RADspeed Pro2024-04-09
04540217071388 - RADspeed Pro2024-04-09

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