FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106463282
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT45PNCUB
Catalog number
SOT45PNCUB
Device description
PCNL PACK
Published
2024-04-16
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
PPENephroscope set

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPENephroscope SetGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106463282PackageGS12In Commercial Distribution
10197106463284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710646328250197106463282
1019710646328410197106463284

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

Sterilization Methods#

Method table
Method

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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

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
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
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
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