FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885425858178
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA4ABTJHF
Catalog number
SBA4ABTJHF
Device description
STERILE BRACHYTHERAPY PACK
Published
2016-06-24
Public version status
Update
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
50885425858178PackageGS11In Commercial Distribution
10885425858170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088542585817850885425858178
1088542585817010885425858170

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

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
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