X45

GUDID 08059307490214

Rotating anode X-ray tube for radiography systems

I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA

X-ray tube housing assembly, diagnostic
Primary Device ID08059307490214
NIH Device Record Key51fb6c21-3d74-44b2-9276-f3f6ab4c0fe2
Commercial Distribution StatusIn Commercial Distribution
Brand NameX45
Version Model Number1.2/2.0
Company DUNS430263475
Company NameI.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108059307490214 [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 Date2020-09-02
Device Publish Date2020-08-25

On-Brand Devices [X45]

08059307490214Rotating anode X-ray tube for radiography systems
08059307490207Rotating anode X-ray tube for radiography systems

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