AccessGUDID - DEVICE: X-SIGHT G/RA Film (40889971201528)

GUDID

Device Identifier (DI) Information

Brand Name: X-SIGHT G/RA Film
Version or Model: X-SIGHT G/RA Film
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1201524
Company Name: CARESTREAM HEALTH, INC.

Primary DI Number: 40889971201528
Issuing Agency: GS1
Commercial Distribution End Date: November 02, 2021
Device Count: 100
Labeler D-U-N-S® Number*: 793169512 *Terms of Use

Device Description: X-SIGHT G/RA Film 10X12in 100SH

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:	Yes
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

FDA Product Code

[?]

Product Code	Product Code Name
IWZ	Film, 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
Handling Environment Humidity: between 30 and 60 Percent (%) Relative Humidity
Storage Environment Temperature: between 4 and 25 Degrees Celsius
Handling Environment Temperature: between 4 and 25 Degrees Celsius
Storage Environment Humidity: between 30 and 60 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 10e8afa9-81b0-4b0d-b07c-16e4b04bee11
Public Version Date: November 08, 2021
Public Version Number: 3
DI Record Publish Date: September 16, 2016