FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106572207
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
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

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
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25

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
50197106572205CARDINAL HEALTHCardinal Health 200, LLCOKZ2024-04-09
10195594890582CARDINAL HEALTHCardinal Health 200, LLCOKZ2022-10-21
50195594890580CARDINAL HEALTHCardinal Health 200, LLCOKZ2022-10-21