AccessGUDID - DEVICE: T-MAT G/RA (40889976468452)

GUDID

Device Identifier (DI) Information

Brand Name: T-MAT G/RA
Version or Model: T-MAT G/RA
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6468458
Company Name: CARESTREAM HEALTH, INC.

Primary DI Number: 40889976468452
Issuing Agency: GS1
Commercial Distribution End Date: December 22, 2017
Device Count: 50
Labeler D-U-N-S® Number*: 793169512 *Terms of Use

Device Description: T-MAT G/RA Film 50SH 12.7x30.5cm

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?
40977	Dental x-ray film, screen	A screen x-ray film specifically sized and designed for use with dental x-ray systems. It is designed to be sensitive primarily to the wavelengths of light emitted from an image intensifying screen. This x-ray film 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.	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
Storage Environment Humidity: more than 30 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 24 Degrees Celsius
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9d6b445f-1a48-4fd0-9052-af2b8814201f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 16, 2016