IMPRESS-RITE T-MIXING TIPS

Basic Information

• Brand Name: IMPRESS-RITE T-MIXING TIPS
• Primary DI: 00818524020370
• Version / Model: IMP-8104T
• Catalog Number: IMP-8104T
• Company Name: CROWN DELTA CORPORATION
• Labeler DUNS: 030479000
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-29
• Public Version: 2
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: 93567562-500d-4ffe-bb21-923d81ab433e

Device Description

M&S DENTAL IMPRESS-RITE GREEN T-MIXERS (6.5MM) 48/BAG

Device Characteristics

• Single Use: Yes
• 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
EID	Syringe, Restorative And Impression Material	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58399	Dental material mixing nozzle	A device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818524020377	GS1	BAG	48	In Commercial Distribution
Primary	00818524020370	GS1