The Orthodontic Store

Basic Information

• Brand Name: The Orthodontic Store
• Primary DI: 00840326408926
• Version / Model: 187-400
• Catalog Number: 187-400
• 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: a5b32dbd-d484-4848-a387-768326dc6463

Device Description

Boone Gauge

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
DZN	INSTRUMENTS, DENTAL HAND	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44740	Interproximal dental gauge, reusable	A device intended to be used in dentistry to measure the clearance between adjacent teeth (e.g., in orthodontic treatment during reproximation to relieve pressure points between teeth). The device is typically available in a set of stainless steel graduated gauges, typically with notches on the side to help with identification. Device thickness typically ranges from 0.1 mm to 0.5 mm. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10840326408923	GS1	Inner Pack	1	In Commercial Distribution
Primary	00840326408926	GS1

Customer Contacts

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