FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956509511
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT29CPSJO
Catalog number
SOT29CPSJO
Device description
CYSTO PACK
Published
2026-07-31
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
50198956509519PackageGS16In Commercial Distribution
10198956509511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895650951950198956509519
1019895650951110198956509511

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, medicated, single-useA collection of various sterile urological surgical instruments, dressings, pharmaceuticals, and the necessary materials intended to be used to perform a urological surgical procedure; is not dedicated to a specific type of urological surgical procedure. This is a single-use device.

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
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528358HALYARDAVID MEDICAL, INC.NWU2026-08-01
10198956441842CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956497740CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956501881CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956519657CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956537132CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956539174CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956539891CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956346567CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956373945CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956404960CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956439894CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956454224CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956498334CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956498402CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956513037CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956514621CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956518506CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956519428CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956519855CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956520127CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956521179CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956523531CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956530942CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956531338CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956531765CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956532571CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956532649CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956534056CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956534544CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27