RINN®

Basic Information

• Brand Name: RINN®
• Primary DI: D0035408531
• Version / Model: 540853
• Catalog Number: 540853
• Company Name: Dentsply International Inc.
• Labeler DUNS: 795572718
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-03
• Public Version: 4
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: 21875766-69c1-4587-889f-22eba841a409
• Distribution End Date: 2024-02-28

Device Description

UNIVERSAL COLLIMATOR

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: 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
IZX	Collimator, manual, radiographic	Radiology	892.1610	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40960	Dental x-ray system collimator	A beam restriction device used in dental x-ray systems to determine the dimension and direction of the x-ray beam, limiting the effects of scattered radiation. It is used to control the size and shape of the x-ray beam reaching the patient's oral cavity and the film or image receptor. It includes all kinds of x-ray beam restriction devices used in diagnostic dental x-ray systems, such as cones and slit collimators. The device is typically designed for use with a specific dental x-ray system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D0035408531	HIBCC

Customer Contacts

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