FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956346567
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT48CYLSJ
Catalog number
SOT48CYLSJ
Device description
PSSI CYSTO PACK
Published
2026-07-27
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
50198956346565PackageGS13In Commercial Distribution
10198956346567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895634656550198956346565
1019895634656710198956346567

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
10192253072723Curity8441268441262026-10-08
10192253072730Curity8441368441362026-10-08
10192253072747Curity8441468441462026-10-08
10192253072754Curity8441568441562026-10-08
10192253072761Curity8441668441662026-10-08
10192253072778Curity8441768441762026-10-08
10192253072785Curity8442168442162026-10-08
10192253072792Curity8442268442262026-10-08
10192253072808Curity8442368442362026-10-08
10192253072815Curity8442468442462026-10-08
10192253072822Curity8442568442562026-10-08
10885380207150Curity4100A4100A2026-10-08
10885380207167Curity4101A4101A2026-10-08
10885380207174Curity4102A4102A2026-10-08
50885380207202Curity41000410002026-10-08
50885380207219Curity4103A4103A2026-10-08
50885380207226Curity4104A4104A2026-10-08
50885380207233Curity4105A4105A2026-10-08
50885380207240Curity42000420002026-10-08
50885380207257Curity43000430002026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956570733CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-30
10198956396906CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956552548CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956568419CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956568518CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956574564CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956590526CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956593824CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956594074CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956595903CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956388239CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956531697CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25