TruFit™

Basic Information

• Brand Name: TruFit™
• Primary DI: 00190707192242
• Version / Model: 492-52-3023
• Company Name: Ortho Organizers, Inc.
• Labeler DUNS: 062165188
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2025-10-23
• Public Version: 3
• Public Version Date: 2025-12-30
• Public Version Status: Update
• Public Device Record Key: ac666237-b1a7-47b5-83a7-6d7ca08f301c

Device Description

TruFit 2.0 022 SE LR6/7 NC SBT 0T 0DOff DB SB (10PK)

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: MR Unsafe
• 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
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
Unit of Use	10190707192249	GS1
Primary	00190707192242	GS1