AccessGUDID - DEVICE: X-OMATIC Regular Screens (60889971584465)

GUDID

Device Identifier (DI) Information

Brand Name: X-OMATIC Regular Screens
Version or Model: X-OMATIC Regular Screens
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1584465
Company Name: CARESTREAM HEALTH, INC.

Primary DI Number: 60889971584465
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 793169512 *Terms of Use

Device Description: 20PR 15X30CM XMT R HG CP F/PANRMC

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?
34317	X-ray intensifying screen	A device typically considered to be a component of an x-ray film cassette used in diagnostic x-ray applications. It is typically used in pairs with double side emulsion x-ray film. It consists of a backing material, e.g., cardboard, plastic or metal; a reflecting layer of material, e.g., titanium dioxide; an active layer of light-emitting phosphor, e.g., calcium tungstate, barium sulfate, or rare earth material; and a protective layer, typically a plastic coating used to reduce static electricity and allow cleaning. It is used to reduce the x-ray dose to the patient and to allow for shorter exposure times to reduce motion artefact on exposed film.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EAM	Screen, intensifying, 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 Temperature: between 10 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f045a40e-9482-49c0-b789-f8a32ffbb5fb
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 16, 2016