Phoenix Stainless Steel

Basic Information

• Brand Name: Phoenix Stainless Steel
• Primary DI: 05060779991508
• Version / Model: S-1B67-UR375
• Catalog Number: S-1B67-UR375
• Company Name: PHOENIX ORTHODONTICS INC
• Labeler DUNS: 002092976
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-08-17
• Public Version: 2
• Public Version Date: 2024-01-15
• Public Version Status: Update
• Public Device Record Key: 55897b1b-44c3-432d-b5fb-ab3fa263a220

Device Description

OPT 1 MOLAR BAND UP RIGHT 6/7 SIZE 37.5 PK5

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
ECM	BAND, PREFORMED, ORTHODONTIC	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38734	Orthodontic metal band	A thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to 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	05060779991515	GS1
Primary	05060779991508	GS1

Customer Contacts

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