Orthoquest

Basic Information

• Brand Name: Orthoquest
• Primary DI: 00843471158746
• Version / Model: 115-26MM
• Catalog Number: 115-26MM
• Company Name: Young Innovations, Inc.
• Labeler DUNS: 004193103
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-01
• Public Version: 2
• Public Version Date: 2023-04-18
• Public Version Status: Update
• Public Device Record Key: 92180ba5-45fd-4929-a62b-2f6929ed5c10
• Distribution End Date: 2023-04-17

Device Description

Ss 019X025 26Mm 4-Loop Keyhole

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
DZC	WIRE, ORTHODONTIC	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41397	Orthodontic archwire	A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. 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	10843471158743	GS1	Inner Pack	10	Not in Commercial Distribution	2023-04-17
Primary	00843471158746	GS1

Customer Contacts

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