AccessGUDID - DEVICE: Varex Imaging (08718755002775)

GUDID

Device Identifier (DI) Information

Brand Name: Varex Imaging
Version or Model: ICX1997B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Varex Imaging Corporation

Primary DI Number: 08718755002775
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080513718 *Terms of Use

Device Description: An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposure Control (AEC) in delivering the proper x-ray dose in medical radiography. This is a device out of the Ionization Chambers series.

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?
38326	Ionization chamber radiation measuring probe	An electrically isolated or electronically connected gas-filled radiation detection chamber operated in the "ionization chamber" voltage region. It is used with portable survey meters, stationary radiation monitors or analytical counting instruments. The incident radiation sets up a characteristic "saturated current" within the chamber. A number of probes with different size chambers and chamber wall thicknesses are needed to cover the possible range of radiation energies and doses. It is very stable over time and may be used for accurate dosimetry measurements, e.g., source calibrations and inter-comparisons. For accurate measurements, temperature and pressure corrections are needed.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZO	Generator, High-Voltage, 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: d028dac6-798f-438c-bc63-674f2b2b6e89
Public Version Date: March 14, 2022
Public Version Number: 1
DI Record Publish Date: March 04, 2022