Premium Plus

Basic Information

• Brand Name: Premium Plus
• Primary DI: D838001WHITE4
• Version / Model: 001-WHITE
• Company Name: Premium Plus International Limited
• Labeler DUNS: 668367758
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2019-12-25
• Public Version: 1
• Public Version Date: 2020-01-02
• Public Version Status: New
• Public Device Record Key: ba2a7fdc-b717-4332-87bd-82ae5c0f60f4

Device Description

Dental oral evacuators

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: Yes
• 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
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37434	Dental suction system cannula, single-use	A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D838001WHITE8	HIBCC	CASE	4	In Commercial Distribution
Package	D838001WHITE6	HIBCC	BOX	10	In Commercial Distribution
Primary	D838001WHITE4	HIBCC
Unit of Use	D838001WHITE0	HIBCC