FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956595194
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOTOCUPBAB
Catalog number
SOTOCUPBAB
Device description
URETEROSCOPY PACK
Published
2026-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956595192PackageGS14In Commercial Distribution
10198956595194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895659519250198956595192
1019895659519410198956595194

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956106666CARDINAL HEALTHSAN23PMPRHSAN23PMPRH2026-10-23
10198956201606CARDINAL HEALTHPOV2ASNULPOV2ASNUL2026-10-23
10198956318748CARDINAL HEALTHSAN42RPIRBSAN42RPIRB2026-10-23
10198956332553CARDINAL HEALTHPNVNNECHVPNVNNECHV2026-10-23
10198956409552CARDINAL HEALTHSCV40CVKUGSCV40CVKUG2026-10-23
10198956433113CARDINAL HEALTHSEN40EPWEDSEN40EPWED2026-10-23
10198956460942CARDINAL HEALTHSBA69BPSABSBA69BPSAB2026-10-23
10198956463417CARDINAL HEALTHPB41GLLAEPB41GLLAE2026-10-23
10198956487918CARDINAL HEALTHSOPHDTPMSCSOPHDTPMSC2026-10-23
10198956504899CARDINAL HEALTHSNE12CRKGOSNE12CRKGO2026-10-23
10198956505766CARDINAL HEALTHSOPCNARCRESOPCNARCRE2026-10-23
10198956506572CARDINAL HEALTHSOT7ECPSSESOT7ECPSSE2026-10-23
10198956508682CARDINAL HEALTHSOP53TPNABSOP53TPNAB2026-10-23
10198956530157CARDINAL HEALTHSAN11IRLVLSAN11IRLVL2026-10-23
10198956530799CARDINAL HEALTH34-0748B34-0748B2026-10-23
10198956534834CARDINAL HEALTHSANOCCCPOFSANOCCCPOF2026-10-23
10198956544123CARDINAL HEALTHPG08GMPCBPG08GMPCB2026-10-23
10198956548923CARDINAL HEALTHSNE33SPMACSNE33SPMAC2026-10-23
10198956549524CARDINAL HEALTHSBA11LYMMJSBA11LYMMJ2026-10-23
10198956553552CARDINAL HEALTHSOP41TPSGGSOP41TPSGG2026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956506572CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-23
10198956598553CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-23
10198956613157CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-23
10198956615397CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-23
06936603237397GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237403GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237410GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237427GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237434GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237441GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237458GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237465GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237489GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237496GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
06936603237502GI Procedure KitYangzhou Fartley Medical Instrument Technology Co., LtdNWU2026-10-22
10198956553903CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956569331CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956595965CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956598355CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956602236CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956605442CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956605497CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956605640CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956607743CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956609723CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956609976CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956612648CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10809160540756HALYARDAVID MEDICAL, INC.NWU2026-10-16
10198956565388CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-15
10198956596054CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-15