Ortho Specialties

Basic Information

• Brand Name: Ortho Specialties
• Primary DI: 00840326420447
• Version / Model: 702-228
• Catalog Number: 702-228
• Company Name: Young Innovations, Inc.
• Labeler DUNS: 004193103
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-18
• Public Version: 2
• Public Version Date: 2024-04-15
• Public Version Status: Update
• Public Device Record Key: d3fb90d5-982f-43d5-a197-2fe1b27cf823
• Distribution End Date: 2024-04-13

Device Description

Bracket, MBT, Lower Right 2nd Bicuspid w/hook, .022

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
EJF	BRACKET, METAL, ORTHODONTIC	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38734	Orthodontic metal band	A thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. This is a single-patient device intended to be 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	10840326420444	GS1	Inner Pack	1	Not in Commercial Distribution	2024-04-13
Primary	00840326420447	GS1

Customer Contacts

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