Phoenix Optimal 2X

Basic Information

• Brand Name: Phoenix Optimal 2X
• Primary DI: 05060772890600
• Version / Model: D-O2X210-OLR4H
• Catalog Number: D-O2X210-OLR4H
• Company Name: PHOENIX ORTHODONTICS INC
• Labeler DUNS: 002092976
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-08-17
• Public Version: 3
• Public Version Date: 2024-09-03
• Public Version Status: Update
• Public Device Record Key: 1789c19d-e71d-45bc-a705-5788540af12e
• Distribution End Date: 2024-09-02

Device Description

OPTIMAL 2X .022 SS BOND OFFSET L R 1ST BICUSPID HK -12T:0A PK10

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 Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
EJF	BRACKET, METAL, ORTHODONTIC	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46581	Orthodontic bracket, metal	A metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be 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	05060772890617	GS1
Primary	05060772890600	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]