Operating Room Innovations, Inc SG-1

GUDID 26975424191642

Shield Guards-Removable Peel Away, 2 per Pouch

OPERATING ROOM INNOVATIONS, INC.

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Primary Device ID26975424191642
NIH Device Record Key58242163-c5bf-453b-a568-59eaac8ae79c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOperating Room Innovations, Inc
Version Model NumberSG-1
Catalog NumberSG-1
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
GS106975424191648 [Primary]
GS126975424191642 [Package]
Contains: 06975424191648
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 Date2023-04-13
Device Publish Date2023-04-05

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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