FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956442030
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT23SBNL1
Catalog number
SOT23SBNL1
Device description
PROSTATE SEED BIOP NEW HAN PK
Published
2026-04-27
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
50198956442038PackageGS16In Commercial Distribution
10198956442030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895644203850198956442038
1019895644203010198956442030

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
10198956141018CARDINAL HEALTHSNEHFNSASASNEHFNSASA2026-10-06
10198956171954CARDINAL HEALTHSCVCGCVMHCSCVCGCVMHC2026-10-06
10198956286672CARDINAL HEALTHPOV20110MPOV20110M2026-10-06
10198956301511CARDINAL HEALTHSOPPDKRROCSOPPDKRROC2026-10-06
10198956306059CARDINAL HEALTHSOP51SHSRGSOP51SHSRG2026-10-06
10198956314351CARDINAL HEALTHSNE8BSPBPGSNE8BSPBPG2026-10-06
10198956339156CARDINAL HEALTHOR2224609BOR2224609B2026-10-06
10198956340268CARDINAL HEALTHSAN22IPMRDSAN22IPMRD2026-10-06
10198956348776CARDINAL HEALTHPL23CEMEFPL23CEMEF2026-10-06
10198956354494CARDINAL HEALTHSOPHFAPMRCSOPHFAPMRC2026-10-06
10198956362666CARDINAL HEALTHSOT54CPDRCSOT54CPDRC2026-10-06
10198956371019CARDINAL HEALTHSER5BCLHCCSER5BCLHCC2026-10-06
10198956379824CARDINAL HEALTHSOP21SAFECSOP21SAFEC2026-10-06
10198956391215CARDINAL HEALTHSANDHAGFHCSANDHAGFHC2026-10-06
10198956397859CARDINAL HEALTH34-9706C34-9706C2026-10-06
10198956399129CARDINAL HEALTH26-7824E26-7824E2026-10-06
10198956401846CARDINAL HEALTH34-3264R34-3264R2026-10-06
10198956402416CARDINAL HEALTHSOP13OHEXESOP13OHEXE2026-10-06
10198956420526CARDINAL HEALTHSAN4ATPJHCSAN4ATPJHC2026-10-06
10198956439535CARDINAL HEALTHSEN69ESKODSEN69ESKOD2026-10-06

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
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
10197106768266CARDINAL HEALTHCardinal Health 200, LLCOIN2024-09-09