FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594198848
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PUCGPNBM4
Catalog number
PUCGPNBM4
Device description
KIT, BAL PERC NEPHROLITHOTOMY
Published
2021-07-08
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
50195594198846PackageGS11In Commercial Distribution
10195594198848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559419884650195594198846
1019559419884810195594198848

GMDN Terms#

Term, Definition table
TermDefinition
Nephroscopic surgical procedure kit, medicatedA collection of various sterile surgical and endoscopic instruments, dressings, pharmaceuticals, and the necessary materials used to perform a nephroscopic 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
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956543935CARDINAL HEALTHCardinal Health 200, LLCPPE2026-09-22
10198956536869CARDINAL HEALTHCardinal Health 200, LLCPPE2026-07-27
10198956342071CARDINAL HEALTHCardinal Health 200, LLCPPE2026-07-20
10198956491373CARDINAL HEALTHCardinal Health 200, LLCPPE2026-06-05
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
10198956387935CARDINAL 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
10198956293366CARDINAL HEALTHCardinal Health 200, LLCPPE2025-12-11
10198956279605CARDINAL HEALTHCardinal Health 200, LLCPPE2025-12-10
10198956274761CARDINAL 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