FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594890582
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
09D7483C
Catalog number
09D7483C
Device description
EMB IUD PLACEMENT TRAY
Published
2022-10-21
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
OKZEndometrial sampling kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKZEndometrial Sampling KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594890580PackageGS116In Commercial Distribution
10195594890582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559489058050195594890580
1019559489058210195594890582

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, medicatedA collection of various sterile surgical instruments, dressings, pharmaceuticals, and materials intended to be used during obstetrical/gynaecological surgery; it is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific procedure. 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
No natural rubber latex
true

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
10198956052635CARDINAL HEALTHCardinal Health 200, LLCOKZ2025-09-02
50198956052633CARDINAL HEALTHCardinal Health 200, LLCOKZ2025-09-02
10198956089815CARDINAL HEALTHCardinal Health 200, LLCOKZ2025-06-02
50198956089813CARDINAL HEALTHCardinal Health 200, LLCOKZ2025-06-02
10197106771884CARDINAL HEALTHCardinal Health 200, LLCOKZ2024-09-19
50197106771882CARDINAL HEALTHCardinal Health 200, LLCOKZ2024-09-19
10197106747179CARDINAL HEALTHCardinal Health 200, LLCOKZ2024-08-21
50197106747177CARDINAL HEALTHCardinal Health 200, LLCOKZ2024-08-21
10197106738801CARDINAL HEALTHCardinal Health 200, LLCOKZ2024-08-09
50197106738809CARDINAL HEALTHCardinal Health 200, LLCOKZ2024-08-09
10197106572207CARDINAL HEALTHCardinal Health 200, LLCOKZ2024-04-09
50197106572205CARDINAL HEALTHCardinal Health 200, LLCOKZ2024-04-09
50195594890580CARDINAL HEALTHCardinal Health 200, LLCOKZ2022-10-21