AccessGUDID - DEVICE: Medical X-ray Cassette with Green 400 Screens (40889976807121)

GUDID

Device Identifier (DI) Information

Brand Name: Medical X-ray Cassette with Green 400 Screens
Version or Model: Medical X-ray Cassette with Green 400 Screens
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6807127
Company Name: CARESTREAM HEALTH, INC.

Primary DI Number: 40889976807121
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 793169512 *Terms of Use

Device Description: 11X14IN MX CASS E/GREEN 400 SCREEN

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?
40979	Medical x-ray film, screen	A screen x-ray film specifically designed for medical diagnostic imaging applications. It is sensitive primarily to wavelengths of light emitted from an image intensifying screen or other visible light source. It is prepared as an emulsion of light and x-ray sensitive granules on one (single-emulsion film) or both (double-emulsion film) sides of a transparent film base made of cellulose acetate, polyester resin or other appropriate material. This film is not limited to use with x-ray imaging systems but can also be used in a variety of diagnostic imaging modalities using image intensifier technology or matrix formatters to output images, e.g., nuclear medicine or ultrasound.	Active	false
35839	X-ray film cassette, automatic film changing	A housing for x-ray film specifically designed to be used in, and work as part of, an automated x-ray film changing system. The housing is intended to be loaded with x-ray film under appropriate darkroom conditions, and is then inserted into the loading magazine of the film changing system. After exposure, it is held in a receiving magazine until the operator removes it for final processing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IXA	Cassette, radiographic film

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K896708	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
No Device Sizes

Device Record Status

Public Device Record Key: 0c7942b5-826d-4866-b7bf-bf23d7611106
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016