FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106429936
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT11SRNYF
Catalog number
SOT11SRNYF
Device description
UROLOGY SPERM RETRIEVAL PK
Published
2023-11-28
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
50197106429936PackageGS12In Commercial Distribution
10197106429938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710642993650197106429936
1019710642993810197106429938

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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

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
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
50195594336552CARDINAL HEALTHCardinal Health 200, LLCOKW2021-10-01
10195594343545CARDINAL HEALTHCardinal Health 200, LLCOKW2021-09-22
50195594343543CARDINAL HEALTHCardinal Health 200, LLCOKW2021-09-22