First Molar Comb Convert Rotation Tube

Basic Information

• Brand Name: First Molar Comb Convert Rotation Tube
• Primary DI: 00192029024720
• Version / Model: 391-512
• Company Name: TP ORTHODONTICS INC
• Labeler DUNS: 005432299
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-15
• Public Version: 1
• Public Version Date: 2021-03-23
• Public Version Status: New
• Public Device Record Key: 5eb42f85-e199-4e7d-b017-fa97e12b3afa

Device Description

UL 1st Molar Mini Size Torque -10, Tip 0, Distal Offset 7, H.G. 7 0.46 mm x 0.64 mm (.018" x .025") 3.5 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
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	00192029024720	GS1