Maxima Radiopaque Kit

Basic Information

• Brand Name: Maxima Radiopaque Kit
• Primary DI: 00304040000861
• Version / Model: 2283013
• Catalog Number: 2283013
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2021-10-25
• Public Version Status: Update
• Public Device Record Key: 850585ba-d6c4-4344-8cde-058c3c6378d7

Device Description

Maxima Radiopaque Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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
ELM	Denture, plastic, teeth	Dental	872.3590	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38643	Resin artificial teeth	Prefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10304040000868	GS1	KIT	13	In Commercial Distribution
Primary	00304040000861	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Box per 11 set + 2 jar x 40g

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Storage this product in a cool and dry area
• Type: Storage Environment Temperature
• Temperature Range: 2 – 23 Degrees Celsius