Operating Room Innovations, Inc OH-4

GUDID 00854150007378

Face Shield Attached w. AAMI IV Head Covering

OPERATING ROOM INNOVATIONS, INC.

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Primary Device ID00854150007378
NIH Device Record Key328f1593-2120-4a3b-b075-f20e9cb5b7c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameOperating Room Innovations, Inc
Version Model NumberOH-4
Catalog NumberOH-4
Company DUNS080246656
Company NameOPERATING ROOM INNOVATIONS, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100854150007361 [Primary]
GS100854150007378 [Package]
Contains: 00854150007361
Package: Case [25 Units]
In Commercial Distribution

FDA Product Code

LYUAccessory, Surgical Apparel

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-01
Device Publish Date2021-09-23

On-Brand Devices [Operating Room Innovations, Inc]

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

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