Flexible Phosphor Screen GP

Basic Information

• Brand Name: Flexible Phosphor Screen GP
• Primary DI: 40889971631196
• Version / Model: Flexible Phosphor Screen GP
• Catalog Number: 1631191
• Company Name: CARESTREAM HEALTH, INC.
• Labeler DUNS: 793169512
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-16
• Public Version: 1
• Public Version Date: 2018-12-17
• Public Version Status: New
• Public Device Record Key: 15172900-9531-4c03-93b6-59863a60cd40
• Distribution End Date: 2018-12-10

Device Description

FLEX PHOSPHR SCRN FOR 2000RT CASS 35X43

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: Yes
• 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
EAM	Screen, intensifying, radiographic	Radiology	892.1960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44826	Digital imaging storage phosphor screen	A photostimulatable device used in medical imaging applications that is exposed to radiation by a diagnostic imaging x-ray system to record a patient radiation pattern, and then transferred to a computed radiography scanner to produce a digital image of the latent image formed on the device. The device is transported and shielded from room light by a computed radiography cassette.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	60889971631190	GS1	Case	5	Not in Commercial Distribution	2018-12-10
Primary	40889971631196	GS1