Pinnacle Side Shields

Basic Information

• Brand Name: Pinnacle Side Shields
• Primary DI: 00615375003978
• Version / Model: 4700C
• Company Name: METREX RESEARCH, LLC
• Labeler DUNS: 145963778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 4
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: 3256720b-cd8b-4c88-b9a9-985f05caca0e

Device Description

Disposable Prescription Eyewear Shields

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
MMP	Cover, barrier, protective	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58376	Eye splash shield, single-use	A device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or a mask. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	D68347001	HIBCC
Primary	00615375003978	GS1
Unit of Use	00615375006993	GS1

Customer Contacts

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