FDA.reportPublic FDA data

Operating Room Innovations, Inc

Primary DI
00854150007361
Brand
Operating Room Innovations, Inc
Company
Operating Room Innovations, Inc.
Model
OH-4
Catalog number
OH-4
Device description
Face Shield Attached w. AAMI IV Head Covering
Published
2021-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854150007378PackageGS125Not in Commercial Distribution
00854150007361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854150007378008541500073788541500073780854150007378
00854150007361008541500073618541500073610854150007361

GMDN Terms#

Term, Definition table
TermDefinition
Face splash shield, single-useA 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.

Regulatory Flags#

DUNS number
080246656
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854150007392Specialty Anterior Hip DrapeORI-SDL-DAHIPORI-SDL-DAHIP2026-01-01
00854150007408Specialty Lower Extremity DrapeORI-SDL-LEADORI-SDL-LEAD2026-01-01
00854150007422Universal Upper Extremity DrapeORI-SDL-UPXDORI-SDL-UPXD2026-01-01
06975085708605ORIORI-SDL-DAHIPORI-SDL-DAHIP2023-04-03
00850003355016ORISF-4XL-ELSF-4XL-EL2018-11-09
00850003355030ORISF-4XXL-ELSF-4XXL-EL2018-11-09
00854150007002SF-3PL Solofit AAMI III SMS Gown Poly Reinforced LargeSF-3PLSF-3PL2017-03-02
00854150007026SF-3L Solofit AAMI III SMS Gown LargeSF-3LSF-3L2017-03-02
00854150007040SF-3XL Solofit AAMI III SMS Gown X-LargeSF-3XLSF-3XL2017-03-02
00854150007064SF-3PXL Solofit AAMI III SMS Gown Poly Reinforced X-LargeSF-3PXLSF-3PXL2017-03-02
00854150007071SF-3XXL Solofit AAMI III SMS Gown XX-LargeSF-3XXLSF-3XXL2017-03-02
00854150007095SF-3PXXL Solofit AAMI III SMS Gown Poly Reinforced XX-LargeSF-3PXXLSF-3PXXL2017-03-02
00854150007118DS-100 ORI Drop Stop KitDS-100DS-1002017-03-02
00854150007132ORI Self Donning Tabs KitSF-SDT-1SF-SDT-12017-08-01
00854150007156ORISF-4PLSF-4PL2017-10-24
00854150007163ORISF-4XLSF-4XL2017-10-24
00854150007187ORISF-4XXLSF-4XXL2017-10-24
00854150007231ORIUH-3UH-32019-01-07
00854150007248SoloFitSF-4XXXL-ELSF-4XXXL-EL2019-06-03
00854150007262ORIORI-SDL-LEADORI-SDL-LEAD2020-06-30

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