ORJ

Basic Information

• Brand Name: ORJ
• Primary DI: D115J63251251
• Version / Model: J632-5125
• Company Name: Fortune Worldwide LLC
• Labeler DUNS: 949163229
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-04
• Public Version: 1
• Public Version Date: 2022-11-14
• Public Version Status: New
• Public Device Record Key: d41d9590-09e8-47c2-821b-7d7543a902b2

Device Description

Orthodontic Metal Tubes for Teeth Correction

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: No
• 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
DZD	Tube, Orthodontic	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31759	Orthodontic tube	A device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is 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
Primary	D115J63251251	HIBCC