FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956380011
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT4JPNCM2
Catalog number
SOT4JPNCM2
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
50198956380019PackageGS11In Commercial Distribution
10198956380011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895638001950198956380019
1019895638001110198956380011

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
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19
10198956519527CARDINAL HEALTH17-7678I17-7678I2026-10-19
10198956519756CARDINAL HEALTHPO33UEVWBPO33UEVWB2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956180000CARDINAL HEALTHCardinal Health 200, LLCPPE2026-10-19
10198956590397CARDINAL HEALTHCardinal Health 200, LLCPPE2026-10-06
10198956593596CARDINAL HEALTHCardinal Health 200, LLCPPE2026-10-06
10198956568044CARDINAL HEALTHCardinal Health 200, LLCPPE2026-09-29
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
10198956387935CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-03
10198956374584CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-02
10198956280878CARDINAL 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
10198956195431CARDINAL HEALTHCardinal Health 200, LLCPPE2025-09-02