FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106544778
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT23SBNLA
Catalog number
SOT23SBNLA
Device description
PROSTATE SEED BIOP NEW HAN PK
Published
2024-02-19
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
50197106544776PackageGS16In Commercial Distribution
10197106544778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710654477650197106544776
1019710654477810197106544778

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
00885380173700Curity1806G1806G2026-10-26
10192253010015Kangaroo7761507761502026-10-26
10198956294127CARDINAL HEALTHSOPHDTHWWCSOPHDTHWWC2026-10-26
10198956515376CARDINAL HEALTHSBA69FFKWRSBA69FFKWR2026-10-26
10198956516342CARDINAL HEALTHSMA54GLPOISMA54GLPOI2026-10-26
10198956519138CARDINAL HEALTHSMA55CPYKFSMA55CPYKF2026-10-26
10198956542006CARDINAL HEALTH20-485AI20-485AI2026-10-26
10198956555839CARDINAL HEALTHAMN696315EAMN696315E2026-10-26
10198956562905CARDINAL HEALTHSEY57KC00GSEY57KC00G2026-10-26
10198956565784CARDINAL HEALTHSNEOCSPSBCSNEOCSPSBC2026-10-26
10198956566705CARDINAL HEALTHPN41LMLAKPN41LMLAK2026-10-26
10198956568884CARDINAL HEALTH27-9143M27-9143M2026-10-26
10198956573437CARDINAL HEALTHSAN12AIUVFSAN12AIUVF2026-10-26
10198956575028CARDINAL HEALTHSMA73UGKSISMA73UGKSI2026-10-26
10198956576940CARDINAL HEALTHSOP69SH45CSOP69SH45C2026-10-26
10198956577107CARDINAL HEALTHSEN4AEAJHWSEN4AEAJHW2026-10-26
10198956577282CARDINAL HEALTHSBAOCMBKCRSBAOCMBKCR2026-10-26
10198956578869CARDINAL HEALTHSBAOCMJWYJSBAOCMJWYJ2026-10-26
10198956590359CARDINAL HEALTHSBA4QFLFPCSBA4QFLFPC2026-10-26
10198956591981CARDINAL HEALTHSOP69EEKRESOP69EEKRE2026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956337053CARDINAL HEALTHCardinal Health 200, LLCOIN2026-07-20
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
10197106761168CARDINAL HEALTHCardinal Health 200, LLCOIN2024-10-09
50197106761166CARDINAL HEALTHCardinal Health 200, LLCOIN2024-10-09
10197106763919CARDINAL HEALTHCardinal Health 200, LLCOIN2024-09-09