Nexus Universal Intro Kit

Basic Information

• Brand Name: Nexus Universal Intro Kit
• Primary DI: 00841396195310
• Version / Model: 36989
• Catalog Number: 36989
• Company Name: Kerr Corporation
• Labeler DUNS: 199354556
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-12
• Public Version: 1
• Public Version Date: 2020-06-22
• Public Version Status: New
• Public Device Record Key: 9c8e1e25-922f-4e24-ac4e-196a090a74ff

Device Description

Nexus Universal Syringes(s): Clear with Chroma, Nexus Universal Clear, Nexus Universal White, Nexus Universal Yellow, Automix Tips and Optibond Universal bottle w/mixing well.

Device Characteristics

• Single Use: No
• 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
EMA	Cement, Dental	Dental	872.3275	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35870	Dental composite resin	A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841396195310	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	10	Gram

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store Nexus Universal at 2C to 25C (36F to 77F). Refrigerate Optibond Universal between 2C to 8C (36F to 46F). For all other Optibond products refer to their Instructions for Use.