ORTHOSOURCE

Basic Information

• Brand Name: ORTHOSOURCE
• Primary DI: D9114005110
• Version / Model: 4005/11
• Company Name: ORTHOSOURCE
• Labeler DUNS: 151289394
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-24
• Public Version: 2
• Public Version Date: 2022-11-07
• Public Version Status: Update
• Public Device Record Key: c85cc279-b5e0-4536-ae1b-56740344ad4d
• Distribution End Date: 2072-10-25

Device Description

Micro Expansion Screw 6.5 mm

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65679	Orthodontic palate expander/teeth aligner, self-removable	An orthodontic device intended to gradually spread the maxillary arch and/or improve teeth alignment. It is typically in the form of either: 1) a segmented body separated by a palate expander screw; or 2) a spring-like mechanism with clasps and/or wires. It is not fixed to the oral cavity so that it can be temporarily removed and reapplied by the patient during the treatment period (e.g., for eating). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D9114005110	HIBCC