FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106362059
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT11SRN10
Catalog number
SOT11SRN10
Device description
UROLOGY SPERM RETRIEVAL PK
Published
2023-07-21
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
50197106362059PackageGS12In Commercial Distribution
10197106362051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710636205950197106362059
1019710636205110197106362051

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50197106982103CARDINAL HEALTHCardinal Health 200, LLCOKW2025-03-11
50197106193332CARDINAL HEALTHCardinal Health 200, LLCOKW2024-07-03
50197106547883CARDINAL HEALTHCardinal Health 200, LLCOKW2024-04-23
50197106598083CARDINAL HEALTHCardinal Health 200, LLCOKW2024-03-06
50197106429936CARDINAL HEALTHCardinal Health 200, LLCOKW2023-11-28
50197106240623CARDINAL HEALTHCardinal Health 200, LLCOKW2023-04-26
50197106217748CARDINAL HEALTHCardinal Health 200, LLCOKW2023-04-11
50197106010141CARDINAL HEALTHCardinal Health 200, LLCOKW2022-10-21
50195594855411CARDINAL HEALTHCardinal Health 200, LLCOKW2022-09-27
50195594740540CARDINAL HEALTHCardinal Health 200, LLCOKW2022-07-26
50195594719195CARDINAL HEALTHCardinal Health 200, LLCOKW2022-06-28
50195594336552CARDINAL HEALTHCardinal Health 200, LLCOKW2021-10-01
50195594343543CARDINAL HEALTHCardinal Health 200, LLCOKW2021-09-22
50195594319302CARDINAL HEALTHCardinal Health 200, LLCOKW2021-09-02
50888439802687CARDINAL HEALTHCardinal Health 200, LLCOKW2020-04-10
50888439736470CARDINAL HEALTHCardinal Health 200, LLCOKW2020-03-02
50888439654279CARDINAL HEALTHCardinal Health 200, LLCOKW2019-12-16
50888439494752CARDINAL HEALTHCardinal Health 200, LLCOKW2019-05-17
50888439288870CARDINAL HEALTHCardinal Health 200, LLCOKW2018-11-28
50888439189184CARDINAL HEALTHCardinal Health 200, LLCOKW2018-10-23
50887488983354CARDINAL HEALTHCardinal Health 200, LLCOKW2018-05-07