MIN-R 2 Cassette with MIN-R 2190 Screen

Basic Information

• Brand Name: MIN-R 2 Cassette with MIN-R 2190 Screen
• Primary DI: 60889978607334
• Version / Model: MIN-R 2 Cassette with MIN-R 2190 Screen
• Catalog Number: 8607335
• Company Name: CARESTREAM HEALTH, INC.
• Labeler DUNS: 793169512
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-07
• Public Version: 4
• Public Version Date: 2019-03-11
• Public Version Status: Update
• Public Device Record Key: ab385d16-e5df-4c01-b005-f2025127e0ab

Device Description

24X30CM MIN-R2 CASS W/MINR 2190 SCR REF

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
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
Primary	60889978607334	GS1