CR MD1.0 GENERAL CASSETTE

Basic Information

• Brand Name: CR MD1.0 GENERAL CASSETTE
• Primary DI: 05414904160756
• Version / Model: CR MD1.0 GENERAL CASSETTE 15X30
• Catalog Number: 5YEKX
• Company Name: AGFA
• Labeler DUNS: 374444883
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 4
• Public Version Date: 2019-06-14
• Public Version Status: Update
• Public Device Record Key: 0543cd7c-c163-4086-bba4-1c615bee49d9

Device Description

CR MD1.0 GENERAL CASSETTE 15X30

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQB	Solid state x-ray imager (flat panel/digital imager)	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44823	Digital imaging cassette	A device used in medical imaging applications 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, in the process of producing a digital image of a patient radiation pattern.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05414904160756	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K131408	000

Device Sizes

Type	Value	Unit	Text
Length	15	Centimeter
Width	30	Centimeter