AccessGUDID - DEVICE: FireCR (08809466040016)

GUDID

Device Identifier (DI) Information

Brand Name: FireCR
Version or Model: FR01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CG-701
Company Name: Digiray Corp.

Primary DI Number: 08809466040016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557815751 *Terms of Use

Device Description: The FireCR System is ideal for Computed Radiography examinations in busy clinics and specialty practices. Affordable, rugged, compact, lightweight, fast and effective FireCR System enables all imaging functions to be performed with the advanced image management software, a solution that can be adapted most clinical applications.

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":	Yes
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?
35928	Radiography digital imaging scanner	A laser or light-based optical unit designed to convert medical images originally captured on x-ray film or phosphor storage plate (PSP) into a digital format. Examples of this device include devices employing video frame grabbers, and scanners which use lasers or charge-coupled devices. Depending on the design, the digitized images can then be digitally transferred from location to location, archived, or used with other digital image processing, analysis or recording systems.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Weight: 30 Kilogram
Width: 46.4 Centimeter
Length: 70.3 Centimeter
Height: 11.7 Centimeter

Device Record Status

Public Device Record Key: 5d9fbcc7-3df3-4b02-8e7e-0f7032d614bd
Public Version Date: February 07, 2020
Public Version Number: 5
DI Record Publish Date: June 20, 2016