AccessGUDID - DEVICE: C339 E (08059307491402)

GUDID

Device Identifier (DI) Information

Brand Name: C339 E
Version or Model: C339 E
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA

Primary DI Number: 08059307491402
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 430263475 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36593	X-ray system tube rotating anode assembly	A component of an x-ray tube, the rotating anode subassembly provides the means to rotate a disc made of tungsten (W) or an alloy of tungsten at speeds above 3000 revolutions per minute while the x-ray tube is operational. The disc is contained within the vacuum of the glass x-ray tube. The power to effect rotation is provided by a magnetic field produced by stator coils which surround the neck of the x-ray tube outside the glass envelope. This mechanism is used in x-ray tube designs in order to dissipate the heat generated by x-ray tubes and to allow them to withstand the heat generated by large x-ray exposures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITY	Assembly, Tube Housing, X-Ray, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 756773b6-ec84-4a0c-ba47-d74709006ac8
Public Version Date: September 02, 2020
Public Version Number: 1
DI Record Publish Date: August 25, 2020