Phoenix Separators

Basic Information

• Brand Name: Phoenix Separators
• Primary DI: 05060772893502
• Version / Model: E-SBL
• Catalog Number: E-SBL
• Company Name: PHOENIX ORTHODONTICS INC
• Labeler DUNS: 002092976
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• 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: 1ec63384-996d-4efd-9735-34ff3f0a941f

Device Description

BLUE BULK RADIOPAQUE SEPARATORS LARGE PK1000

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ECI	BAND, ELASTIC, ORTHODONTIC	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63708	Orthodontic separator	A non-surgical orthodontic device typically in the form of a loop or ring intended to be placed between adjacent teeth to slowly move them apart to help achieve improved positioning and/or appearance of the teeth; it is not intended for separation of tooth roots. 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	05060772893519	GS1
Primary	05060772893502	GS1

Customer Contacts

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