FDA.reportPublic FDA data

ORI

Primary DI
06975085708605
Brand
ORI
Company
Operating Room Innovations, Inc.
Model
ORI-SDL-DAHIP
Catalog number
ORI-SDL-DAHIP
Device description
Specialty Drape Line-Direct Anterior Hip
Published
2023-04-03
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
KKXDrape, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26975085708609PackageGS15Not in Commercial Distribution
06975085708605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697508570860926975085708609
06975085708605069750857086056975085708605

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.

Regulatory Flags#

DUNS number
080246656
Device count
1
DM 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
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
08056646500291Basic Implant SetOMNIA SRLKKX2026-03-27
08056646500307Implantology SetOMNIA SRLKKX2026-03-27
08056646500321Oral Surgery SetOMNIA SRLKKX2026-03-27
08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
10812564036022MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036077MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036107MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036183MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036190MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036213MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036381MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20080196017017MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277636726MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660943MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660950MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
40884389185781MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277635552MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
40888277357038MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
10080196176700Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496648Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496655Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496686Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497171Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497188Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497195Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497720Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497744Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498239Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29