MAMORAY HD

Basic Information

• Brand Name: MAMORAY HD
• Primary DI: 05414904009345
• Version / Model: MAMORAY HD 24X30
• Catalog Number: EDBU7
• 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: cc026ebe-dc10-48dc-a056-9afe0276c1e0

Device Description

MAMORAY CASSETTE / HD

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
IZH	System, x-ray, mammographic	Radiology	892.1710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35437	X-ray film cassette, manual	A device used in medical imaging applications to shield x-ray film from exposure to room light during transport and insertion into a diagnostic imaging system, film formatter, or film processor. It is typically designed for use with a particular imaging system or image formatting unit and consists of a plastic or metal housing with removable metal or plastic inserts. Some film cassettes used in x-ray applications can incorporate an x-ray grid into the cassette design.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05414904009345	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K790273	000

Device Sizes

Type	Value	Unit	Text
Width	30	Centimeter
Length	24	Centimeter