FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956580893
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT48CPPS4
Catalog number
SOT48CPPS4
Device description
CYSTO PACK
Published
2026-09-22
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
50198956580891PackageGS12In Commercial Distribution
10198956580893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895658089150198956580891
1019895658089310198956580893

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.

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
10192253004489SharpSafety85221852212026-09-24
10192253004502Monoject8522Y8522Y2026-09-24
10192253004557Monoject8533Y8533Y2026-09-24
10192253004571Monoject8536SA8536SA2026-09-24
10192253004632SharpSafety8541SA8541SA2026-09-24
10192253005059Monoject89651896512026-09-24
10192253005080Monoject8967Y8967Y2026-09-24
10192253005493Monoject8506Y8506Y2026-09-24
20885380075169CARDINAL HEALTHUSA-N95-SUSA-N95-S2016-08-02
20885380075183CARDINAL HEALTHUSA-N95-RUSA-N95-R2016-08-02
10198956271418CARDINAL HEALTHSMADKCSOGDSMADKCSOGD2026-09-22
10198956273979CARDINAL HEALTHSNE41APFMASNE41APFMA2026-09-22
10198956313897CARDINAL HEALTHSNE69CRWHESNE69CRWHE2026-09-22
10198956320598CARDINAL HEALTH28-1807Z28-1807Z2026-09-22
10198956333758CARDINAL HEALTHSMA73GLKCHSMA73GLKCH2026-09-22
10198956336667CARDINAL HEALTHSBA57PIOHQSBA57PIOHQ2026-09-22
10198956338661CARDINAL HEALTH08-8060I08-8060I2026-09-22
10198956339255CARDINAL HEALTHSAN23CCPRFSAN23CCPRF2026-09-22
10198956346222CARDINAL HEALTHSMAHDRLAGBSMAHDRLAGB2026-09-22
10198956350434CARDINAL HEALTHPE23THMEHPE23THMEH2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956554283CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956557000CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956557390CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956558557CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956561205CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956578685CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956581036CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956584075CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956585256CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956585638CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956588684CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956588974CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956378247CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-21
10198956445857CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-21
10198956468535CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-21
10198956558878CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-21
10198956567481CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-21
10198956567979CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-21
10198956568556CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-21
10198956585577CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-21
10198956522596CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956535589CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956537644CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956552111CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956571679CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956573666CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956530355CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956548206CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956548213CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956548435CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26