FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106822034
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT44PNHCE
Catalog number
SOT44PNHCE
Device description
PCNL, BTGH PACK
Published
2024-12-18
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
50197106822034PackageGS12In Commercial Distribution
10197106822036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710682203450197106822034
1019710682203610197106822036

GMDN Terms#

Term, Definition table
TermDefinition
Nephroscopic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical and endoscopic instruments, dressings and the necessary materials used to perform a nephroscopic surgical procedure. It does not contain pharmaceuticals. 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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956333275CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-23
50198956340389CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-19
50198956388848CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-19
50198956380019CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-03
50198956387933CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-03
50198956374582CARDINAL HEALTHCardinal Health 200, LLCPPE2026-03-02
50198956280876CARDINAL HEALTHCardinal Health 200, LLCPPE2026-01-05
50198956293425CARDINAL HEALTHCardinal Health 200, LLCPPE2025-12-17
50198956293364CARDINAL HEALTHCardinal Health 200, LLCPPE2025-12-11
50198956279603CARDINAL HEALTHCardinal Health 200, LLCPPE2025-12-10
50198956274769CARDINAL HEALTHCardinal Health 200, LLCPPE2025-12-02
50197106752423CARDINAL HEALTHCardinal Health 200, LLCPPE2025-09-18
50198956195439CARDINAL HEALTHCardinal Health 200, LLCPPE2025-09-02
50198956171907CARDINAL HEALTHCardinal Health 200, LLCPPE2025-08-11
50198956137255CARDINAL HEALTHCardinal Health 200, LLCPPE2025-08-08
50198956154443CARDINAL HEALTHCardinal Health 200, LLCPPE2025-07-28
50198956154757CARDINAL HEALTHCardinal Health 200, LLCPPE2025-07-23
50198956131796CARDINAL HEALTHCardinal Health 200, LLCPPE2025-06-30
50198956101348CARDINAL HEALTHCardinal Health 200, LLCPPE2025-06-05
50198956081619CARDINAL HEALTHCardinal Health 200, LLCPPE2025-05-16
50198956070422CARDINAL HEALTHCardinal Health 200, LLCPPE2025-05-07
50198956025910CARDINAL HEALTHCardinal Health 200, LLCPPE2025-05-05
50197106814671CARDINAL HEALTHCardinal Health 200, LLCPPE2025-04-28
50198956059311CARDINAL HEALTHCardinal Health 200, LLCPPE2025-04-28
00810143891294Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.PPE2025-04-25
50198956062021CARDINAL HEALTHCardinal Health 200, LLCPPE2025-04-23
50197106674596CARDINAL HEALTHCardinal Health 200, LLCPPE2025-04-07
50198956004304CARDINAL HEALTHCardinal Health 200, LLCPPE2025-03-21
50197106964864CARDINAL HEALTHCardinal Health 200, LLCPPE2025-03-06
50197106966028CARDINAL HEALTHCardinal Health 200, LLCPPE2025-03-03