Operating Room Innovations, Inc OH-4

GUDID 00854150007378

Face Shield Attached w. AAMI IV Head Covering

OPERATING ROOM INNOVATIONS, INC.

Face splash shield, single-use

• Primary Device ID: 00854150007378
• NIH Device Record Key: 328f1593-2120-4a3b-b075-f20e9cb5b7c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Operating Room Innovations, Inc
• Version Model Number: OH-4
• Catalog Number: OH-4
• Company DUNS: 080246656
• Company Name: OPERATING ROOM INNOVATIONS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854150007361 [Primary]
GS1	00854150007378 [Package]; Contains: 00854150007361; Package: Case [25 Units]; In Commercial Distribution

FDA Product Code

• LYU: Accessory, Surgical Apparel

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-01
• Device Publish Date: 2021-09-23

On-Brand Devices [Operating Room Innovations, Inc]

• 00854150007378: Face Shield Attached w. AAMI IV Head Covering
• 26975424191642: Shield Guards-Removable Peel Away, 2 per Pouch