FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594336552
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT11SRNY4
Catalog number
SOT11SRNY4
Device description
UROLOGY SPERM RETRIEVAL PK
Published
2021-10-01
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
OKWSeminal fluid collection kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKWSeminal Fluid Collection KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594336552PackageGS12In Commercial Distribution
10195594336554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559433655250195594336552
1019559433655410195594336554

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.

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
10197106911266CARDINAL HEALTHSBA60POLHCSBA60POLHC2026-06-08
10197106983577CARDINAL HEALTHSEN69ERMVDSEN69ERMVD2026-06-08
10198956182264CARDINAL HEALTHSCV43OOTGKSCV43OOTGK2026-06-08
10198956218611CARDINAL HEALTHSOP55AOKFJSOP55AOKFJ2026-06-08
10198956227552CARDINAL HEALTHSEY33EPCAFSEY33EPCAF2026-06-08
10198956279391CARDINAL HEALTH01-0111A01-0111A2026-06-08
10198956312920CARDINAL HEALTHSMA57CESARSMA57CESAR2026-06-08
10198956332096CARDINAL HEALTHSOP32THGMLSOP32THGML2026-06-08
10198956336865CARDINAL HEALTHPN73CRKPBPN73CRKPB2026-06-08
10198956343139CARDINAL HEALTHSOP45HAOCCSOP45HAOCC2026-06-08
10198956359024CARDINAL HEALTHSBA24UPJRGSBA24UPJRG2026-06-08
10198956362932CARDINAL HEALTHSEN48TASABSEN48TASAB2026-06-08
10198956364349CARDINAL HEALTHSBACGRPGRASBACGRPGRA2026-06-08
10198956364783CARDINAL HEALTHSNE38LMCIBSNE38LMCIB2026-06-08
10198956373372CARDINAL HEALTHSOP31EXHNGSOP31EXHNG2026-06-08
10198956373976CARDINAL HEALTHSOP38SHUSHSOP38SHUSH2026-06-08
10198956374119CARDINAL HEALTHSBA56LPSTCSBA56LPSTC2026-06-08
10198956386150CARDINAL HEALTHSEN69SPREBSEN69SPREB2026-06-08
10198956387171CARDINAL HEALTHSBA41PLRSESBA41PLRSE2026-06-08
10198956390430CARDINAL HEALTHSEN37TSPSDSEN37TSPSD2026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956446359CARDINAL HEALTHCardinal Health 200, LLCOKW2026-05-19
10198956408609CARDINAL HEALTHCardinal Health 200, LLCOKW2026-04-15
10198956292734CARDINAL HEALTHCardinal Health 200, LLCOKW2026-04-07
10197106982105CARDINAL HEALTHCardinal Health 200, LLCOKW2025-03-11
50197106982103CARDINAL HEALTHCardinal Health 200, LLCOKW2025-03-11
10197106193334CARDINAL HEALTHCardinal Health 200, LLCOKW2024-07-03
50197106193332CARDINAL HEALTHCardinal Health 200, LLCOKW2024-07-03
10197106547885CARDINAL HEALTHCardinal Health 200, LLCOKW2024-04-23
50197106547883CARDINAL HEALTHCardinal Health 200, LLCOKW2024-04-23
10197106598085CARDINAL HEALTHCardinal Health 200, LLCOKW2024-03-06
50197106598083CARDINAL HEALTHCardinal Health 200, LLCOKW2024-03-06
10197106429938CARDINAL HEALTHCardinal Health 200, LLCOKW2023-11-28
50197106429936CARDINAL HEALTHCardinal Health 200, LLCOKW2023-11-28
10197106362051CARDINAL HEALTHCardinal Health 200, LLCOKW2023-07-21
50197106362059CARDINAL HEALTHCardinal Health 200, LLCOKW2023-07-21
10197106240625CARDINAL HEALTHCardinal Health 200, LLCOKW2023-04-26
50197106240623CARDINAL HEALTHCardinal Health 200, LLCOKW2023-04-26
10197106217740CARDINAL HEALTHCardinal Health 200, LLCOKW2023-04-11
50197106217748CARDINAL HEALTHCardinal Health 200, LLCOKW2023-04-11
10197106010143CARDINAL HEALTHCardinal Health 200, LLCOKW2022-10-21
50197106010141CARDINAL HEALTHCardinal Health 200, LLCOKW2022-10-21
10195594855413CARDINAL HEALTHCardinal Health 200, LLCOKW2022-09-27
50195594855411CARDINAL HEALTHCardinal Health 200, LLCOKW2022-09-27
10195594740542CARDINAL HEALTHCardinal Health 200, LLCOKW2022-07-26
50195594740540CARDINAL HEALTHCardinal Health 200, LLCOKW2022-07-26
10195594719197CARDINAL HEALTHCardinal Health 200, LLCOKW2022-06-28
50195594719195CARDINAL HEALTHCardinal Health 200, LLCOKW2022-06-28
10195594336554CARDINAL HEALTHCardinal Health 200, LLCOKW2021-10-01
10195594343545CARDINAL HEALTHCardinal Health 200, LLCOKW2021-09-22
50195594343543CARDINAL HEALTHCardinal Health 200, LLCOKW2021-09-22