CR Cassettes for Vita Systems

Basic Information

• Brand Name: CR Cassettes for Vita Systems
• Primary DI: 60889978041978
• Version / Model: CR Cassettes for Vita Systems
• Catalog Number: 8041972
• Company Name: CARESTREAM HEALTH, INC.
• Labeler DUNS: 793169512
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 33ef7964-78a5-4af2-a192-7a95ce9ed3c0

Device Description

P-O-C 120/140 DENTAL PAN PKG, GP2

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: Yes
• Has Lot/Batch Number: No
• 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

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	60889978041978	GS1

Premarket Submissions

Submission Number	Supplement Number
K945039	000