AccessGUDID - DEVICE: FireCR Spark (08809466040313)

GUDID

Device Identifier (DI) Information

Brand Name: FireCR Spark
Version or Model: FR31
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CG-301
Company Name: Digiray Corp.

Primary DI Number: 08809466040313
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557815751 *Terms of Use

Device Description: The FireCR Spark System is ideal for Computed Radiography examinations in busy clinics and specialty practices. Affordable, rugged, compact, lightweight, fast and effective FireCR Spark 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?
17904	Computed radiography digital imaging scanner	A device/device assembly designed to be used with an analogue x-ray system to capture radiographic images and then generate digital x-ray images from them as part of a two-step process (computed radiography) for image viewing, storage, or hard-copy printing; it is not dedicated to dental use. It consists of an image reader/scanner and may also include an exposure unit with imaging receptor (e.g., a cassette containing a plate), or additional supportive hardware (e.g., a printer). The image is acquired on a photostimulable substance (e.g., a phosphor screen mounted on a cassette plate) and converted into an electrical analogue signal in a laser scanner.	Active	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 [?]
K133120	000

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: 21.5 Kilogram
Width: 44.4 Centimeter
Length: 79.5 Centimeter
Height: 13.4 Centimeter

Device Record Status

Public Device Record Key: 504c8b5b-b5f0-4bbd-87a4-07f1d21dc995
Public Version Date: July 25, 2024
Public Version Number: 8
DI Record Publish Date: October 27, 2016