FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956534056
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PU36CYHR3
Catalog number
PU36CYHR3
Device description
KIT, HRZ CYSTO
Published
2026-07-27
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
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956534054PackageGS13In Commercial Distribution
10198956534056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895653405450198956534054
1019895653405610198956534056

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, medicatedA collection of various sterile surgical and endoscopic instruments (e.g., trocars, sleeves, cannulae), dressings, pharmaceuticals, and the necessary materials used to perform a laparoscopic surgical procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
50885380213234Kendall3320533205B2026-10-28
50885380213241Kendall3320633206B2026-10-28
50885380213258Kendall3320733207B2026-10-28
10885380169922CARDINAL HEALTH212WPR212WPR2020-01-13
20884521100449Monoject8611U8611U2016-09-24
20884521100456Monoject8612U8612U2016-09-24
20192253024668Monoject888120201888812020182026-07-15
10192253040203Argyle1604091604092025-01-08
10192253040210Argyle43201432012025-01-08
10192253040241Argyle43308433082025-01-08
10192253040258Argyle43309433092025-01-08
10192253040265Argyle43311433112025-01-08
10192253040289Argyle888816011988881601192025-01-08
10192253040326Argyle888816040888881604082025-01-08
10192253040333Argyle888816042488881604242025-01-08
10192253040340Argyle888816043288881604322025-01-08
10192253040395Argyle888816083888881608382025-01-08
10192253040401Argyle888816085388881608532025-01-08
10192253046656Kendall55566BAMD55566BAMD2023-10-09
10195594567743CARDINAL HEALTHSBACNUBOL3SBACNUBOL32022-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00677964154133Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154140Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154157Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154164Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154171Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154188Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154195Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154201Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154218Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154225Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154232Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154249Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154256Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
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00677964154270Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154287Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154294Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
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00677964154317Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
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00677964154331Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154348Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154355Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154362Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154379Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154386Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154393Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154409Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154416Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154423Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28