FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106761168
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT23SBNLB
Catalog number
SOT23SBNLB
Device description
PROSTATE SEED BIOP NEW HAN PK
Published
2024-10-09
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
OINProstate seeding kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OINProstate Seeding KitRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106761166PackageGS16In Commercial Distribution
10197106761168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710676116650197106761166
1019710676116810197106761168

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
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
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
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956468412CARDINAL HEALTHCardinal Health 200, LLCOIN2026-05-25
10198956442030CARDINAL HEALTHCardinal Health 200, LLCOIN2026-04-27
10198956365995CARDINAL HEALTHCardinal Health 200, LLCOIN2026-04-07
10198956388383CARDINAL HEALTHCardinal Health 200, LLCOIN2026-04-06
10198956297838CARDINAL HEALTHCardinal Health 200, LLCOIN2026-02-02
50198956297836CARDINAL HEALTHCardinal Health 200, LLCOIN2026-02-02
10198956315433CARDINAL HEALTHCardinal Health 200, LLCOIN2026-01-13
50198956315431CARDINAL HEALTHCardinal Health 200, LLCOIN2026-01-13
10198956144491CARDINAL HEALTHCardinal Health 200, LLCOIN2025-07-03
50198956144499CARDINAL HEALTHCardinal Health 200, LLCOIN2025-07-03
10198956085039CARDINAL HEALTHCardinal Health 200, LLCOIN2025-05-19
50198956085037CARDINAL HEALTHCardinal Health 200, LLCOIN2025-05-19
10198956080003CARDINAL HEALTHCardinal Health 200, LLCOIN2025-05-14
50198956080001CARDINAL HEALTHCardinal Health 200, LLCOIN2025-05-14
10197106993200CARDINAL HEALTHCardinal Health 200, LLCOIN2025-03-14
50197106993208CARDINAL HEALTHCardinal Health 200, LLCOIN2025-03-14
10197106845295CARDINAL HEALTHCardinal Health 200, LLCOIN2024-11-26
50197106845293CARDINAL HEALTHCardinal Health 200, LLCOIN2024-11-26
10197106811771CARDINAL HEALTHCardinal Health 200, LLCOIN2024-11-15
50197106811779CARDINAL HEALTHCardinal Health 200, LLCOIN2024-11-15
10197106811085CARDINAL HEALTHCardinal Health 200, LLCOIN2024-10-28
50197106811083CARDINAL HEALTHCardinal Health 200, LLCOIN2024-10-28
10197106798485CARDINAL HEALTHCardinal Health 200, LLCOIN2024-10-16
50197106798483CARDINAL HEALTHCardinal Health 200, LLCOIN2024-10-16
10197106799673CARDINAL HEALTHCardinal Health 200, LLCOIN2024-10-14
50197106799671CARDINAL HEALTHCardinal Health 200, LLCOIN2024-10-14
50197106761166CARDINAL HEALTHCardinal Health 200, LLCOIN2024-10-09
10197106763919CARDINAL HEALTHCardinal Health 200, LLCOIN2024-09-09
10197106768266CARDINAL HEALTHCardinal Health 200, LLCOIN2024-09-09
50197106763917CARDINAL HEALTHCardinal Health 200, LLCOIN2024-09-09