FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106993200
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN29BRC10
Catalog number
SAN29BRC10
Device description
BRACHYTHERAPY PACK
Published
2025-03-14
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
50197106993208PackageGS14In Commercial Distribution
10197106993200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710699320850197106993208
1019710699320010197106993200

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

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
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
50197106763917CARDINAL HEALTHCardinal Health 200, LLCOIN2024-09-09