FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956590793
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOTWGCPSFA
Catalog number
SOTWGCPSFA
Device description
CYSTO CUSTOM PACK
Published
2026-10-12
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
50198956590791PackageGS12In Commercial Distribution
10198956590793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895659079150198956590791
1019895659079310198956590793

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
10198956077348CARDINAL HEALTHSCV57RAKPQSCV57RAKPQ2026-10-12
10198956137547CARDINAL HEALTHPV35VKMBCPV35VKMBC2026-10-12
10198956194632CARDINAL HEALTHSAN33MPMPCSAN33MPMPC2026-10-12
10198956276437CARDINAL HEALTHSOPCNBERVBSOPCNBERVB2026-10-12
10198956301719CARDINAL HEALTHSOP53PKBSCSOP53PKBSC2026-10-12
10198956331259CARDINAL HEALTH32-1024F32-1024F2026-10-12
10198956333611CARDINAL HEALTHPOCGHNWTGPOCGHNWTG2026-10-12
10198956352230CARDINAL HEALTHSAN40SLRWBSAN40SLRWB2026-10-12
10198956361041CARDINAL HEALTHSOP44SPKSCSOP44SPKSC2026-10-12
10198956384439CARDINAL HEALTHSOP32LSISFSOP32LSISF2026-10-12
10198956388376CARDINAL HEALTHSOPCGTHOMESOPCGTHOME2026-10-12
10198956391239CARDINAL HEALTHSOT12CYMOCSOT12CYMOC2026-10-12
10198956399051CARDINAL HEALTHSUT44BPSCBSUT44BPSCB2026-10-12
10198956421240CARDINAL HEALTHSEY23CTRCPSEY23CTRCP2026-10-12
10198956460393CARDINAL HEALTHSEN30EEPRBSEN30EEPRB2026-10-12
10198956463875CARDINAL HEALTH02-0891H02-0891H2026-10-12
10198956471887CARDINAL HEALTHSCV54VCWMUSCV54VCWMU2026-10-12
10198956491298CARDINAL HEALTH31-1019F31-1019F2026-10-12
10198956493803CARDINAL HEALTHSNE11CR83GSNE11CR83G2026-10-12
10198956507425CARDINAL HEALTHSBA42BPSMBSBA42BPSMB2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956391239CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956553408CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956556522CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956564701CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956574595CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956577077CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956584150CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956590809CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956592742CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956598324CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956601826CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956601840CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956362666CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956486300CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956502703CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956539365CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956555563CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956567795CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956569317CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956578241CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956578593CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956582538CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956586628CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956588530CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956593787CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956594753CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956597617CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956598232CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956598928CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956599444CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06