RINN®

Basic Information

• Brand Name: RINN®
• Primary DI: D0035501481
• Version / Model: 550148
• Company Name: Dentsply International Inc.
• Labeler DUNS: 795572718
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2020-10-21
• Public Version Status: Update
• Public Device Record Key: 9ccd1d12-13f9-4f9b-bb74-5aee65f5d2bd

Device Description

FASTab™ Bitewing Holder & Uni-Grip 360 Holder. Contains: 100 FASTab™ Bitewing Holders, 25 Uni-Grip® 360 Sensor Holders, 125 Size 1.5/2 Rinn® Tight Sensor Covers and 1 Positioning Arm and Ring

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGZ	Holder, film, x-ray	Dental	872.1905	1
PEM	Dental barriers and sleeves	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16205	Dental x-ray film holder, reusable	A device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device.	No	Active
33878	Cable/lead/sensor/probe cover, non-sterile	A non-sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier to protect the contents from soiling and contamination so that the non-sterile contents may be used in the vicinity of, or enter into a hygienic area, e.g., a sterile surgical field. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D0035501481	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius