0.6/1.2P18DE-85

GUDID 04540217046416

SHIMADZU CORPORATION

X-ray tube housing assembly, diagnostic
Primary Device ID04540217046416
NIH Device Record Key65d1d84b-e09a-4767-a78e-ccfbe999f9f4
Commercial Distribution StatusIn Commercial Distribution
Brand Name0.6/1.2P18DE-85
Version Model Number582-24556
Company DUNS690558747
Company NameSHIMADZU CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS104540217046416 [Primary]

FDA Product Code

ITYAssembly, Tube Housing, X-Ray, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-09
Device Publish Date2018-06-07

On-Brand Devices [0.6/1.2P18DE-85]

04540217046416582-24556
04540217062294582-24556-50

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.