AccessGUDID - DEVICE: CR MD4.0R GENERAL PLATE (05414904043288)

GUDID

Device Identifier (DI) Information

Brand Name: CR MD4.0R GENERAL PLATE
Version or Model: CR MD4.0R GENERAL PLATE 35X35
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E5PRW
Company Name: AGFA

Primary DI Number: 05414904043288
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 374444883 *Terms of Use

Device Description: CR MD4.0R GENERAL PLATE 35CM X 35CM

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):	Yes
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQB	Solid state x-ray imager (flat panel/digital imager)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141602	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
Width: 35 Centimeter
Length: 35 Centimeter

Device Record Status

Public Device Record Key: 89ce3c94-6778-429f-94b6-effb743f7a83
Public Version Date: June 14, 2019
Public Version Number: 4
DI Record Publish Date: September 01, 2016