Premium Plus

Basic Information

• Brand Name: Premium Plus
• Primary DI: D838090PINK4
• Version / Model: 090-PINK
• Company Name: Premium Plus International Limited
• Labeler DUNS: 668367758
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-07
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 78320cb8-8d89-4086-b5f7-e853de8cc723

Device Description

Napkin Holders

Device Characteristics

• Single Use: No
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRD	Unit, Operative Dental, Accessories	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34961	Towel clamp, reusable	A surgical instrument designed to hold together surgical towels and/or drapes, or for securing other devices such as cables/leads, during an operation/intervention. It is made of metallic or polymer materials and is available in a variety of sizes and designs (e.g., two blades joined at their midpoints, single alpha-shaped device, various gripping jaws); it is commonly known as a towel clamp, towel forceps, or towel clip. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D838090PINK8	HIBCC	CASE	100	In Commercial Distribution
Primary	D838090PINK4	HIBCC