The Orthodontic Store

Basic Information

• Brand Name: The Orthodontic Store
• Primary DI: 00843471163344
• Version / Model: 900-544
• Catalog Number: 900-544
• Company Name: Young Innovations, Inc.
• Labeler DUNS: 004193103
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-02
• Public Version: 2
• Public Version Date: 2023-04-18
• Public Version Status: Update
• Public Device Record Key: 72bd23eb-1b49-4d48-87dc-7ba5ef304f17
• Distribution End Date: 2023-04-17

Device Description

Trumpeted Weldable Non-Convertible Buccal Tubes, Single, Roth, Upper Left, .022

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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZD	TUBE, ORTHODONTIC	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31759	Orthodontic tube	A device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10843471163341	GS1	Inner Pack	1	Not in Commercial Distribution	2023-04-17
Primary	00843471163344	GS1

Customer Contacts

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