Evolve

Basic Information

• Brand Name: Evolve
• Primary DI: 00810152071014
• Version / Model: 6051-18-64
• Catalog Number: 6051-18-64
• Company Name: Orthoshop, LLC
• Labeler DUNS: 129808388
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-11-24
• Public Version: 1
• Public Version Date: 2023-12-04
• Public Version Status: New
• Public Device Record Key: 88d8cfec-8ed6-4d8a-b7c2-9949aee4e21f

Device Description

Orthodontic Buccal Tubes Evolve MBT .018" Bondable Single Non-Convertible U6R/U6L/L6R/L6L

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: 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	10810152071011	GS1
Primary	00810152071014	GS1