C30 - Rotating anode X-ray tube unit for radiography - I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA

Duns Number:430263475

Device Description: Rotating anode X-ray tube unit for radiography systems

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More Product Details

Catalog Number

-

Brand Name

C30

Version/Model Number

C30

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ITY

Product Code Name

Assembly, Tube Housing, X-Ray, Diagnostic

Device Record Status

Public Device Record Key

4c559de9-77ab-4c14-9f91-3d294c6d69e5

Public Version Date

September 01, 2020

Public Version Number

1

DI Record Publish Date

August 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 148