MIN-R 2 Cassette with MIN-R EV 150 Screen

Basic Information

• Brand Name: MIN-R 2 Cassette with MIN-R EV 150 Screen
• Primary DI: 40889971117034
• Version / Model: MIN-R 2 Cassette with MIN-R EV 150 Screen
• Catalog Number: 1117035
• Company Name: CARESTREAM HEALTH, INC.
• Labeler DUNS: 793169512
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 150
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 64326d16-1609-40c0-bf83-54276b4b5b9b

Device Description

18X24CM MIN-R2 CASS W/EV 150 SCR

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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
IXA	Cassette, radiographic film	Radiology	892.1850	2
EAM	Screen, intensifying, radiographic	Radiology	892.1960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34317	X-ray intensifying screen	A device typically considered to be a component of an x-ray film cassette used in diagnostic x-ray applications. It is typically used in pairs with double side emulsion x-ray film. It consists of a backing material, e.g., cardboard, plastic or metal; a reflecting layer of material, e.g., titanium dioxide; an active layer of light-emitting phosphor, e.g., calcium tungstate, barium sulfate, or rare earth material; and a protective layer, typically a plastic coating used to reduce static electricity and allow cleaning. It is used to reduce the x-ray dose to the patient and to allow for shorter exposure times to reduce motion artefact on exposed film.	No	Active
35839	X-ray film cassette, automatic film changing	A housing for x-ray film specifically designed to be used in, and work as part of, an automated x-ray film changing system. The housing is intended to be loaded with x-ray film under appropriate darkroom conditions, and is then inserted into the loading magazine of the film changing system. After exposure, it is held in a receiving magazine until the operator removes it for final processing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	60889971117038	GS1	Case	6	In Commercial Distribution
Primary	40889971117034	GS1
Unit of Use	00889971117036	GS1