AccessGUDID - DEVICE: CR MM3.0 EXTREMITIES CASSETTE (05414904018200)

GUDID

Device Identifier (DI) Information

Brand Name: CR MM3.0 EXTREMITIES CASSETTE
Version or Model: CR MM3.0 EXTREMITIES CASSETTE 18X24
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EU5TF
Company Name: AGFA

Primary DI Number: 05414904018200
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 374444883 *Terms of Use

Device Description: CR MM3.0 EXTR CAS 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:	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?
44823	Digital imaging cassette	A device intended to be used in diagnostic x-ray imaging to hold and shield a phosphor plate (not included) from exposure to room light during transport and insertion into a computed radiography (CR) scanner to produce a digital image of a patient radiation pattern. This is a reusable device.	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 [?]
K041701	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
Length: 18 Centimeter
Width: 24 Centimeter

Device Record Status

Public Device Record Key: c5ec598f-3286-4ee6-abc9-2faade36a4d1
Public Version Date: June 19, 2024
Public Version Number: 5
DI Record Publish Date: September 01, 2016