AccessGUDID - DEVICE: Varex Imaging (08718755002201)

GUDID

Device Identifier (DI) Information

Brand Name: Varex Imaging
Version or Model: OPTICA20-00-005-001-EU1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Varex Imaging Nederland B.V.

Primary DI Number: 08718755002201
Issuing Agency: GS1
Commercial Distribution End Date: May 20, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 413223942 *Terms of Use

Device Description: x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(Collimator) This is a device out of the Optica 20 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?
42253	Manual-aperture-control diagnostic x-ray system collimator, non-motorized	A standard, non-motorized, diagnostic x-ray beam-limiting device whose aperture size/length/shutter assembly must be manually adjusted in order to match the size of the x-ray beam to the size of the x-ray cassette in use. It includes designs with manual controls that operate one or more shutter pairs and also designs that require the addition or removal of attachments or extensions that allow the operator to alter the size and shape of the exit beam from a cone or cylinder. An x-ray collimator is used to limit the effects of scattered radiation on image quality and to provide patient protection by eliminating exposure to non-target body areas.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZX	Collimator, Manual, Radiographic

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: 8b57a7c5-07f7-49ef-89d6-ed9cf5f18cf2
Public Version Date: May 20, 2025
Public Version Number: 3
DI Record Publish Date: February 07, 2022