AccessGUDID - DEVICE: Flexible Phosphor Screen GP (40889971631196)

GUDID

Device Identifier (DI) Information

Brand Name: Flexible Phosphor Screen GP
Version or Model: Flexible Phosphor Screen GP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1631191
Company Name: CARESTREAM HEALTH, INC.

Primary DI Number: 40889971631196
Issuing Agency: GS1
Commercial Distribution End Date: December 10, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 793169512 *Terms of Use

Device Description: FLEX PHOSPHR SCRN FOR 2000RT CASS 35X43

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?
44826	Digital imaging storage phosphor screen	A photostimulatable device used in medical imaging applications that is exposed to radiation by a diagnostic imaging x-ray system to record a patient radiation pattern, and then transferred to a computed radiography scanner to produce a digital image of the latent image formed on the device. The device is transported and shielded from room light by a computed radiography cassette.	Obsolete	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 15172900-9531-4c03-93b6-59863a60cd40
Public Version Date: December 17, 2018
Public Version Number: 1
DI Record Publish Date: November 16, 2018