The Orthodontic Store

Basic Information

• Brand Name: The Orthodontic Store
• Primary DI: 00840326403648
• Version / Model: 213-012
• Catalog Number: 213-012
• Company Name: Young Innovations, Inc.
• Labeler DUNS: 004193103
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-01
• Public Version: 1
• Public Version Date: 2022-11-09
• Public Version Status: New
• Public Device Record Key: d038c50c-5537-492a-9246-44ecfdf339ec

Device Description

Preformed Ligature Wire, .012

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: 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
DZC	WIRE, ORTHODONTIC	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14457	Wire ligature	A sterile, thin metal cord intended to be tied tightly around a blood vessel, the pedicle of a tumour, or other structure in order to constrict it. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10840326403645	GS1	Inner Pack	1000	In Commercial Distribution
Primary	00840326403648	GS1

Customer Contacts

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