FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106598085
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMAOCMTGR3
Catalog number
SMAOCMTGR3
Device description
MESA TESA PACK WOMENS CENTER
Published
2024-03-06
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
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
50197106598083PackageGS12In Commercial Distribution
10197106598085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710659808350197106598083
1019710659808510197106598085

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

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