FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594890580
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
OTC
false
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.

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
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
10195594890582CARDINAL HEALTHCardinal Health 200, LLCOKZ2022-10-21