FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885425233687
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PU12OTGUR
Catalog number
PU12OTGUR
Device description
PERCUT NEPHROL,GEORGETOWN,KIT
Published
2017-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NWOKit, catheter, urinary (exludes hiv testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWOKit, Catheter, Urinary (Exludes Hiv Testing)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885425233685PackageGS11In Commercial Distribution
10885425233687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088542523368550885425233685
1088542523368710885425233687

GMDN Terms#

Term, Definition table
TermDefinition
Nephroscopic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical and endoscopic instruments, dressings and the necessary materials used to perform a nephroscopic surgical procedure. It does not contain pharmaceuticals. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
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
07333387043913GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387043944GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387043975GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044002GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044033GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044064GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044095GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044125GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044156GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044187GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044217GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044248GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044279GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044309GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044330GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044361GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387043999GentleCathTMOASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETINWO2024-06-01
07333387044170GentleCathTMOASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETINWO2024-06-01
07333387044255GentleCathTMOASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETINWO2024-06-01
07333387043678SimPro™ SetWellspect ABNWO2024-05-02
07333387043739SimPro™ SetWellspect ABNWO2024-05-02
07333387043852SimPro™ SetWellspect ABNWO2024-05-02
07333387043494SimPro™ SetWellspect ABNWO2024-05-01
07333387043555SimPro™ SetWellspect ABNWO2024-05-01
07333387043616SimPro™ SetWellspect ABNWO2024-05-01
07333387043647SimPro™ SetWellspect ABNWO2024-05-01
07333387043579SimPro™ SetWellspect ABNWO2024-05-01
07333387043524SimPro™ SetWellspect ABNWO2023-08-28
07333387043586SimPro™ SetWellspect ABNWO2023-08-28
07333387043708SimPro™ SetWellspect ABNWO2023-08-28