FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106572205
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN23EMNLA
Catalog number
SAN23EMNLA
Device description
EMBO PACK NEW HAN
Published
2024-04-09
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
50197106572205PackageGS18In Commercial Distribution
10197106572207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710657220550197106572205
1019710657220710197106572207

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

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
10195594890582CARDINAL HEALTHCardinal Health 200, LLCOKZ2022-10-21
50195594890580CARDINAL HEALTHCardinal Health 200, LLCOKZ2022-10-21