FDA.reportPublic FDA data

CONVERTORS

Primary DI
10885380064234
Brand
CONVERTORS
Company
Cardinal Health 200, LLC
Model
29369
Catalog number
29369
Device description
Tiburon Beach Chair Shoulder Drape
Published
2016-06-28
Public version status
Update
Distribution status
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
KKKSUDAN IV

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKKSudan IvHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380064232PackageGS15In Commercial Distribution
10885380064234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538006423250885380064232
1088538006423410885380064234

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
961027315
Device count
1
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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841336101012Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00841336108813Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00841336108998Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00841336114630Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
10841336108810Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
10841336108995Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
10841336114637Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00840216101784ASP Medical Asp Global, LLCKKK2022-08-02
10840216101781ASP Medical Asp Global, LLCKKK2022-08-02
10634916809401Side DrapeSTANDARD TEXTILE CO., INC.KKK2021-06-11
10888277563889MedlineMEDLINE INDUSTRIES, INC.KKK2021-02-05
40888277563880MedlineMEDLINE INDUSTRIES, INC.KKK2021-02-05
10080196895410MedlineMEDLINE INDUSTRIES, INC.KKK2021-01-26
10080196747924MedlineMEDLINE INDUSTRIES, INC.KKK2020-12-17
00851354004264Sterile DrapeAVINGER, INC.KKK2019-03-21
20845225012698DIGITAL IVUS STERILE EQUIPEMENT COVERVOLCANO CORPORATIONKKK2017-03-02
10080196308200MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
10080196722938MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
10080196915033MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
40080196308201MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
00801902081490ARROWTELEFLEX INCORPORATEDKKK2016-09-16
30801902081491ARROWTELEFLEX INCORPORATEDKKK2016-09-16
20845225012681SpinVision STERILE EQUIPEMENT COVERVOLCANO CORPORATIONKKK2016-09-08
10845225012707R-100 STERILE EQUIPMENT COVERPhilips Image Guided Therapy CorporationKKK2016-09-08
50885380064232CONVERTORSCardinal Health 200, LLCKKK2016-06-28