Premium Plus

Basic Information

• Brand Name: Premium Plus
• Primary DI: D838BC339960YL2
• Version / Model: B-C3399-60YL
• Company Name: Premium Plus International Limited
• Labeler DUNS: 668367758
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2020-01-02
• Public Version: 1
• Public Version Date: 2020-01-10
• Public Version Status: New
• Public Device Record Key: f1e435dc-7edb-4b4f-90fc-afc8debab0e3

Device Description

Disposable Prophy Angles

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46938	Dental polishing cup, single-use	A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D838BC339960YL8	HIBCC	case	4	In Commercial Distribution
Primary	D838BC339960YL2	HIBCC
Unit of Use	D838BC339960YL0	HIBCC