FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106982105
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMAOCMTGR4
Catalog number
SMAOCMTGR4
Device description
MESA TESA PACK WOMENS CENTER
Published
2025-03-11
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
50197106982103PackageGS12In Commercial Distribution
10197106982105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710698210350197106982103
1019710698210510197106982105

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
10192253004205Monoject1525SA1525SA2026-07-13
10192253004410Monoject8507MW8507MW2026-07-13
10192253004540Monoject8533SA8533SA2026-07-13
10192253004588Monoject8537MW8537MW2026-07-13
10192253004625SharpSafety8540SA8540SA2026-07-13
10192253004885Monoject8900MW8900MW2026-07-13
10192253005127Monoject8979MW8979MW2026-07-13
10192253005509Monoject8525Y8525Y2026-07-13
10192253071894Argyle47802478022026-07-13
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29

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
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
50195594343543CARDINAL HEALTHCardinal Health 200, LLCOKW2021-09-22