FDA.reportPublic FDA data

Universal Upper Extremity Drape

Primary DI
00854150007422
Brand
Universal Upper Extremity Drape
Company
Operating Room Innovations, Inc.
Model
ORI-SDL-UPXD
Catalog number
ORI-SDL-UPXD
Device description
ORI Universal Upper Extremity Drape
Published
2026-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975085708551PreviousGS10
00854150007422PrimaryGS10
10854150007429Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
06975085708551069750857085516975085708551
00854150007422008541500074228541500074220854150007422
1085415000742910854150007429

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080246656
Device count
5
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
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
00854150007286ORISS-EVACSS-EVAC2020-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998192814Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998304996Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305016Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305030Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305078Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305092Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305115Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305139Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305153Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312373Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312397Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312434Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312458Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312472Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312496Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329678Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329708Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329739Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329760Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329791Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329821Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329852Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330032Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330124Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330216Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330278Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330308Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330346Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330360Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330438Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23