FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10887488932385
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT23NPSEA
Catalog number
SOT23NPSEA
Device description
NEPHROSTOMY PACK
Published
2018-10-25
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
50887488932383PackageGS110In Commercial Distribution
10887488932385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748893238350887488932383
1088748893238510887488932385

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956428201CARDINAL HEALTH26-2755C26-2755C2026-10-01
10198956512474CARDINAL HEALTH28A5420I28A5420I2026-10-01
10198956524316CARDINAL HEALTH34A5387R34A5387R2026-10-01
10198956537385CARDINAL HEALTH28-6325B28-6325B2026-10-01
10198956563087CARDINAL HEALTH34-2454E34-2454E2026-10-01
10198956587298CARDINAL HEALTH40-6487C40-6487C2026-10-01
10885380214714Curity8441368441362026-09-30
10885380214738Curity8441568441562026-09-30
10885380214707Curity8441268441262026-09-28
10885380214721Curity8441468441462026-09-28
10885380214745Curity8441668441662026-09-28
10885380214752Curity8441768441762026-09-28
10885380214769Curity8442168442162026-09-28
10885380214776Curity8442268442262026-09-28
10885380214783Curity8442368442362026-09-28
10885380214790Curity8442468442462026-09-28
10885380214806Curity8442568442562026-09-28
20192253017561Medi-Trace Cadence22660P22660P2024-02-28
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
50885380050365CARDINAL HEALTHCA901CHCA901CH2021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
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