FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956387935
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT4JPNCM3
Catalog number
SOT4JPNCM3
Device description
PK PERC NEPH CM
Published
2026-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PPENephroscope set

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPENephroscope SetGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956387933PackageGS11In Commercial Distribution
10198956387935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895638793350198956387933
1019895638793510198956387935

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 Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956348301CARDINAL HEALTHCardinal Health 200, LLCPPE2026-04-27
10198956462489CARDINAL HEALTHCardinal Health 200, LLCPPE2026-04-27
10198956467057CARDINAL HEALTHCardinal Health 200, LLCPPE2026-04-27
10198956091504CARDINAL HEALTHCardinal Health 200, LLCPPE2026-04-06
10198956268531CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-26
10198956333277CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-23
50198956333275CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-23
10198956340381CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-19
10198956388840CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-19
50198956340389CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-19
50198956388848CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-19
10198956380011CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-03
50198956380019CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-03
50198956387933CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-03
10198956374584CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-02
50198956374582CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-02
10198956280878CARDINAL HEALTHCardinal Health 200, LLCPPE2026-01-05
50198956280876CARDINAL HEALTHCardinal Health 200, LLCPPE2026-01-05
10198956293427CARDINAL HEALTHCardinal Health 200, LLCPPE2025-12-17
50198956293425CARDINAL HEALTHCardinal Health 200, LLCPPE2025-12-17
10198956293366CARDINAL HEALTHCardinal Health 200, LLCPPE2025-12-11
50198956293364CARDINAL HEALTHCardinal Health 200, LLCPPE2025-12-11
10198956279605CARDINAL HEALTHCardinal Health 200, LLCPPE2025-12-10
50198956279603CARDINAL HEALTHCardinal Health 200, LLCPPE2025-12-10
10198956274761CARDINAL HEALTHCardinal Health 200, LLCPPE2025-12-02
50198956274769CARDINAL HEALTHCardinal Health 200, LLCPPE2025-12-02
10198956214255CARDINAL HEALTHCardinal Health 200, LLCPPE2025-10-01
10198956211377CARDINAL HEALTHCardinal Health 200, LLCPPE2025-09-30
10197106752425CARDINAL HEALTHCardinal Health 200, LLCPPE2025-09-18
10198956195431CARDINAL HEALTHCardinal Health 200, LLCPPE2025-09-02