FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956577206
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOTOCCYKCI
Catalog number
SOTOCCYKCI
Device description
CYSTO PACK
Published
2026-11-03
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
50198956577204PackageGS12In Commercial Distribution
10198956577206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895657720450198956577204
1019895657720610198956577206

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
10198956519664CARDINAL HEALTHSOT73CYCHCSOT73CYCHC2026-11-03
10198956545199CARDINAL HEALTH03E0114D03E0114D2026-11-03
10198956548800CARDINAL HEALTHSVA73RVKAGSVA73RVKAG2026-11-03
10198956559851CARDINAL HEALTH08A6335B08A6335B2026-11-03
10198956569805CARDINAL HEALTHSOP73TJKMCSOP73TJKMC2026-11-03
10198956575646CARDINAL HEALTH34-016AF34-016AF2026-11-03
10198956579873CARDINAL HEALTHORC548814BORC548814B2026-11-03
10198956582019CARDINAL HEALTHSBA54LCVVCSBA54LCVVC2026-11-03
10198956592971CARDINAL HEALTHSMA13CSSGFSMA13CSSGF2026-11-03
10198956600904CARDINAL HEALTH03B3645M03B3645M2026-11-03
10198956603806CARDINAL HEALTHPOHDASVCNOPOHDASVCNO2026-11-03
10198956603936CARDINAL HEALTHSOPHDUTVCOSOPHDUTVCO2026-11-03
10198956607231CARDINAL HEALTH03C8060P03C8060P2026-11-03
10198956607811CARDINAL HEALTHSOP13EPJNBSOP13EPJNB2026-11-03
10198956611047CARDINAL HEALTHSOT43CPPPBSOT43CPPPB2026-11-03
10198956612433CARDINAL HEALTHSOP73TJCR8SOP73TJCR82026-11-03
10198956612556CARDINAL HEALTHSOP73TJCR9SOP73TJCR92026-11-03
10198956614406CARDINAL HEALTHSUT40CBJU1SUT40CBJU12026-11-03
10198956615465CARDINAL HEALTHSOP12TJ55LSOP12TJ55L2026-11-03
10198956616455CARDINAL HEALTHSBAHDMNMJFSBAHDMNMJF2026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956519664CARDINAL HEALTHCardinal Health 200, LLCNWU2026-11-03
10198956611047CARDINAL HEALTHCardinal Health 200, LLCNWU2026-11-03
10198956621558CARDINAL HEALTHCardinal Health 200, LLCNWU2026-11-03
10198956623057CARDINAL HEALTHCardinal Health 200, LLCNWU2026-11-03
10198956253209CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956552302CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956555693CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956558168CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956584013CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956591127CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956598737CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956608481CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956608559CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956620346CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
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