AccessGUDID - DEVICE: CR HD5.0 AEC DETECTOR (05414904044186)

GUDID

Device Identifier (DI) Information

Brand Name: CR HD5.0 AEC DETECTOR
Version or Model: CR HD5.0 AEC DETECTOR 18X24
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5PCPT
Company Name: Agfa HealthCare NV

Primary DI Number: 05414904044186
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 282853795 *Terms of Use

Device Description: CR HD5.0 AEC DETECTOR 18X24CM

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:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Digital imaging cassette/storage phosphor screen	A combination device for medical imaging applications that consists of a cassette used to hold and shield an attached storage phosphor screen from exposure to room light during transport and insertion into a diagnostic imaging x-ray system, and a computed radiography scanner. The photostimulatable storage phosphor screen is exposed to radiation by the x-ray system to record a patient radiation pattern. The cassette is then loaded into a laser scanner capable of reading the latent image formed on the storage phosphor screen to produce a digital image.

GMDN Preferred Term Name

GMDN Definition

Digital imaging cassette/storage phosphor screen

A combination device for medical imaging applications that consists of a cassette used to hold and shield an attached storage phosphor screen from exposure to room light during transport and insertion into a diagnostic imaging x-ray system, and a computed radiography scanner. The photostimulatable storage phosphor screen is exposed to radiation by the x-ray system to record a patient radiation pattern. The cassette is then loaded into a laser scanner capable of reading the latent image formed on the storage phosphor screen to produce a digital image.

FDA Product Code

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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

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Size Type Text
Length: 18 Centimeter
Width: 24 Centimeter

Device Record Status

Public Device Record Key: e1f5499c-031a-441f-b1ae-9b6128b8f6df
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2016