FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106811779
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN33PBAHB
Catalog number
SAN33PBAHB
Device description
PROC BRACHY THERAPY PACK WPH
Published
2024-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
50197106811779PackageGS12In Commercial Distribution
10197106811771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710681177950197106811779
1019710681177110197106811771

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956468412CARDINAL HEALTHCardinal Health 200, LLCOIN2026-05-25
50198956297836CARDINAL HEALTHCardinal Health 200, LLCOIN2026-02-02
50198956315431CARDINAL HEALTHCardinal Health 200, LLCOIN2026-01-13
50198956144499CARDINAL HEALTHCardinal Health 200, LLCOIN2025-07-03
50198956085037CARDINAL HEALTHCardinal Health 200, LLCOIN2025-05-19
50198956080001CARDINAL HEALTHCardinal Health 200, LLCOIN2025-05-14
50197106993208CARDINAL HEALTHCardinal Health 200, LLCOIN2025-03-14
50197106845293CARDINAL HEALTHCardinal Health 200, LLCOIN2024-11-26
50197106811083CARDINAL HEALTHCardinal Health 200, LLCOIN2024-10-28
50197106798483CARDINAL HEALTHCardinal Health 200, LLCOIN2024-10-16
50197106799671CARDINAL HEALTHCardinal Health 200, LLCOIN2024-10-14
50197106761166CARDINAL HEALTHCardinal Health 200, LLCOIN2024-10-09
50197106763917CARDINAL HEALTHCardinal Health 200, LLCOIN2024-09-09
50197106768264CARDINAL HEALTHCardinal Health 200, LLCOIN2024-09-09
50197106741953CARDINAL HEALTHCardinal Health 200, LLCOIN2024-08-21
50197106731268CARDINAL HEALTHCardinal Health 200, LLCOIN2024-08-01
50197106719334CARDINAL HEALTHCardinal Health 200, LLCOIN2024-07-10
50197106617616CARDINAL HEALTHCardinal Health 200, LLCOIN2024-05-03
50197106544776CARDINAL HEALTHCardinal Health 200, LLCOIN2024-02-19
50197106311422CARDINAL HEALTHCardinal Health 200, LLCOIN2023-11-28
50197106477548CARDINAL HEALTHCardinal Health 200, LLCOIN2023-10-30
50197106416189CARDINAL HEALTHCardinal Health 200, LLCOIN2023-08-29
50197106174560CARDINAL HEALTHCardinal Health 200, LLCOIN2023-06-20
50197106186570CARDINAL HEALTHCardinal Health 200, LLCOIN2023-03-15
50197106151431CARDINAL HEALTHCardinal Health 200, LLCOIN2023-02-22
50197106129638CARDINAL HEALTHCardinal Health 200, LLCOIN2023-02-17
50197106018505CARDINAL HEALTHCardinal Health 200, LLCOIN2022-10-31
50195594836403CARDINAL HEALTHCardinal Health 200, LLCOIN2022-09-30
50195594790200CARDINAL HEALTHCardinal Health 200, LLCOIN2022-08-19
50195594746993CARDINAL HEALTHCardinal Health 200, LLCOIN2022-07-06