AccessGUDID - DEVICE: Clarix Imaging Corps (00860007231605)

GUDID

Device Identifier (DI) Information

Brand Name: Clarix Imaging Corps
Version or Model: VSI-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Clarix Imaging Corporation

Primary DI Number: 00860007231605
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080262024 *Terms of Use

Device Description: The Clarix Imaging Volumetric Specimen Imager (VSI) is a portable, fully shielded cabinet X-ray system that provides high resolution 2D and 3D radiographic images of surgically excised specimens.

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):	No
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?
42280	Tissue specimen x-ray system IVD	An assembly of devices designed to produce an x-ray image of a tissue sample (e.g., stereotactic biopsy cores taken during mammographic procedures) and/or an amputated body part, by generating and controlling x-ray beams and recording the absorption patterns of the x-rays. The system typically includes a cabinet where the specimen is placed and a screen; the image is generated via digital imaging methods.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MWP	Cabinet, x-ray system

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between -20 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aa35d42a-6d52-491d-8d86-b3bb906ea4ca
Public Version Date: August 09, 2024
Public Version Number: 1
DI Record Publish Date: August 01, 2024