FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106738801
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN23EMNL1
Catalog number
SAN23EMNL1
Device description
EMBO PACK NEW HAN
Published
2024-08-09
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
50197106738809PackageGS18In Commercial Distribution
10197106738801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710673880950197106738809
1019710673880110197106738801

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological 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

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
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
50195594890580CARDINAL HEALTHCardinal Health 200, LLCOKZ2022-10-21