FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439189186
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMAOCMTGRA
Catalog number
SMAOCMTGRA
Device description
MESA TESA PACK WOMENS CENTER
Published
2018-10-23
Public version status
Update
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
50888439189184PackageGS12In Commercial Distribution
10888439189186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843918918450888439189184
1088843918918610888439189186

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
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
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