FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956498334
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA69RPKRC
Catalog number
SBA69RPKRC
Device description
ROBOTICS PACK
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
50198956498332PackageGS11In Commercial Distribution
10198956498334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895649833250198956498332
1019895649833410198956498334

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.

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
10192253072037CARDINAL HEALTHALMASK5ALMASK52026-07-29
10192253072044CARDINAL HEALTHAMMASK4AMMASK42026-07-29
10192253072051CARDINAL HEALTHAXLMASK6AXLMASK62026-07-29
10192253072068CARDINAL HEALTHCHIMASK3CHIMASK32026-07-29
10192253072075CARDINAL HEALTHINFMASK1INFMASK12026-07-29
10192253072082CARDINAL HEALTHNEOMASK0NEOMASK02026-07-29
10192253072105CARDINAL HEALTHTODMASK2TODMASK22026-07-29
10192253025699Dover888876051688887605162023-11-21
10192253025705Dover888876051888887605182023-11-21
10192253025712Dover888876052088887605202023-11-21
10192253025750Dover888876301888887630182023-11-21
10192253025774Dover888876302288887630222023-11-21
10192253026344Dover35603560-2022-04-12
10192253028201Dover62086208-2024-10-14
10192253030365Dover888849206688884920662025-04-07
10192253031836DoverP4P16ULDP4P16ULD-2024-08-22
10192253068573Dover33053305-2026-01-16
10192253068634Dover61556155-2026-01-16
10197106541029CARDINAL HEALTH01A1360C01A1360C2024-03-06
10197106741030CARDINAL HEALTH03-2242D03-2242D2024-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956346567CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956373945CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956404960CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956439894CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956454224CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956498402CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956513037CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956514621CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956518506CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956519428CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956519855CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956520127CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956521179CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956523531CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956530942CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956531338CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956531765CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956532571CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956532649CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956534056CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956534544CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956535251CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956535398CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956536098CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956536142CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
00677964153877Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-07-20
00677964153921Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-07-20
00677964153976Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-07-20
00677964154089Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-07-20
00677964154096Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-07-20