PremierPro

Basic Information

• Brand Name: PremierPro
• Primary DI: 00818566019769
• Version / Model: 2496
• Catalog Number: 2496
• Company Name: SVS LLC
• Labeler DUNS: 831375089
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-02
• Public Version: 1
• Public Version Date: 2020-08-10
• Public Version Status: New
• Public Device Record Key: 27db74e7-c1b2-4066-8200-6dd8dde80533

Device Description

Protective Eye Wear, Full Face Shield 24/bx

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: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11961	Face splash shield, single-use	A clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818566019766	GS1	case	4	In Commercial Distribution
Primary	00818566019769	GS1

Customer Contacts

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