Face Shield with Replacement Visors

Basic Information

• Brand Name: Face Shield with Replacement Visors
• Primary DI: 14048223041618
• Version / Model: Z9070013
• Catalog Number: Z9070013
• Company Name: Pajunk GmbH Medizintechnologie
• Labeler DUNS: 317654283
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-08-04
• Public Version: 2
• Public Version Date: 2021-03-12
• Public Version Status: Update
• Public Device Record Key: 7f626da0-4a82-40dd-b7f4-2fccabc2da6a
• Distribution End Date: 2025-03-15

Device Description

Face Shield with Replacement Visors class II (Face Shield 10 pieces +

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: 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
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
Unit of Use	04048223041611	GS1
Primary	14048223041618	GS1

Customer Contacts

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