FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106300664
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT12PCUVC
Catalog number
SOT12PCUVC
Device description
PED CYSTO PK
Published
2023-09-07
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
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106300662PackageGS14In Commercial Distribution
10197106300664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710630066250197106300662
1019710630066410197106300664

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
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
10885380152412CARDINAL HEALTHCAX2304BACAX2304BA2017-10-12
10885380152429CARDINAL HEALTHCAX2304BDCAX2304BD2017-10-12
10885380152559CARDINAL HEALTHCAX2330LACAX2330LA2021-10-27
10885380152566CARDINAL HEALTHCAX2330LDCAX2330LD2021-10-27
10885380171109CARDINAL HEALTHCAX1230LACAX1230LA2020-06-21
10885380171116CARDINAL HEALTHCAX1230LDCAX1230LD2020-06-21
10885380171147CARDINAL HEALTHCAX3030LACAX3030LA2020-06-21
10885380171154CARDINAL HEALTHCAX3030LDCAX3030LD2020-06-21
10885380164545CARDINAL HEALTHCAX5030LACAX5030LA2020-03-18
10885380164552CARDINAL HEALTHCAX5030LDCAX5030LD2020-03-18
10198956286306CARDINAL HEALTHSOPOCLRWSHSOPOCLRWSH2026-08-26
10198956330221CARDINAL HEALTHSBA5FLCABBSBA5FLCABB2026-08-26
10198956346246CARDINAL HEALTHSCVHDVPAGCSCVHDVPAGC2026-08-26
10198956373105CARDINAL HEALTHSNE43LMSUBSNE43LMSUB2026-08-26
10198956384330CARDINAL HEALTHSMA45DCWPBSMA45DCWPB2026-08-26
10198956409767CARDINAL HEALTHSEN18EAVBOSEN18EAVBO2026-08-26
10198956417533CARDINAL HEALTHSEY13EPLHMSEY13EPLHM2026-08-26
10198956423633CARDINAL HEALTHPOCGEXBLJPOCGEXBLJ2026-08-26
10198956437746CARDINAL HEALTH38-8433D38-8433D2026-08-26
10198956461048CARDINAL HEALTHSOP18FTSTMSOP18FTSTM2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160531860HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531877HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531914HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531921HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531945HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531952HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531976HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531983HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531990HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532010HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532034HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532041HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532058HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532089HalyardAVID MEDICAL, INC.LRO2026-08-27
10198956437746CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956504462CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956509078CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956511163CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956523814CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956524446CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956531703CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956534896CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956534971CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956535107CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956535473CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956537576CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956544499CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956547636CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956548404CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956549937CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26