FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594037886
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
17A5327C
Catalog number
17A5327C
Device description
PELVIC EXAM
Published
2021-10-08
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
MLTPelvic exam kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLTPelvic Exam KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594037886PackageGS15In Commercial Distribution
10195594037888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559403788650195594037886
1019559403788810195594037888

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
50198956327328CARDINAL HEALTHCardinal Health 200, LLCMLT2026-03-09
50198956270273CARDINAL HEALTHCardinal Health 200, LLCMLT2025-12-11
50198956273533CARDINAL HEALTHCardinal Health 200, LLCMLT2025-12-11
00653160388985MEDLINEMEDLINE INDUSTRIES, INC.MLT2025-08-02
40198459445218MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-07-28
40198459383749MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-07-02
40198459389208MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-07-02
40198459363727MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-06-09
40198459351748MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-06-02
50198956037647CARDINAL HEALTHCardinal Health 200, LLCMLT2025-05-21
40198459323714Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-18
40198459325138Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-18
40198459326227Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-18
10198459312953Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-07
40198459315818Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-07
50198956019087CARDINAL HEALTHCardinal Health 200, LLCMLT2025-04-03
50197106946365CARDINAL HEALTHCardinal Health 200, LLCMLT2025-03-17
40198459273552Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-03-02
40198459268725Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-02-23
50197106952083CARDINAL HEALTHCardinal Health 200, LLCMLT2025-02-17
10198459260889Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-02-16
40198459257026Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-02-09
50197106921027CARDINAL HEALTHCardinal Health 200, LLCMLT2025-01-28
50197106641222CARDINAL HEALTHCardinal Health 200, LLCMLT2025-01-09
50197106899838CARDINAL HEALTHCardinal Health 200, LLCMLT2025-01-09
40198459222048Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-29
40198459225568Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-29
40198459200763Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-01
40198459192464Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-11-24
40198459173227Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-11-17