ORI

Basic Information

• Brand Name: ORI
• Primary DI: 00854150007231
• Version / Model: UH-3
• Catalog Number: UH-3
• Company Name: OPERATING ROOM INNOVATIONS, INC.
• Labeler DUNS: 080246656
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-07
• Public Version: 2
• Public Version Date: 2020-04-06
• Public Version Status: Update
• Public Device Record Key: 378ee62e-38e7-4f79-bf2f-28cfef5107a4

Device Description

UH-3 –Face Shield, attached with Full Covering

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPY	Shield, Protective, Personnel	Radiology	892.6500	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	10854150007238	GS1	Case	50	In Commercial Distribution
Primary	00854150007231	GS1

Customer Contacts

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