FDA.reportPublic FDA data

Dover

Primary DI
50192253030028
Brand
Dover
Company
Cardinal Health 200, LLC
Model
8884730398
Catalog number
8884730398
Device description
MALE EXTERNAL CATHETER, HARD TIP
Published
2024-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EXJDEVICE, INCONTINENCE, UROSHEATH TYPE, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXJDevice, Incontinence, Urosheath Type, SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253030028PackageGS1144In Commercial Distribution
10192253030020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225303002850192253030028
1019225303002010192253030020

GMDN Terms#

Term, Definition table
TermDefinition
Ureteral catheterA flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. 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
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
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
20192253030188DoverCardinal Health 200, LLCEXJ2025-04-01
50192253030097DoverCardinal Health 200, LLCEXJ2024-12-17
50192253030035DoverCardinal Health 200, LLCEXJ2024-10-15
16936881133388Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16936881133395Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16936881133432Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16936881133456Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16944932725482Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16944932725499Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16944932725505Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16944932725512Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16944932725529Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16944932725536Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16944932725543Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16944932725550Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16944932725567Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
16936881133500Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-10
16936881133524Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-10
16944932725574Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-10
16944932730714Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-10
16944932730721Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-10
16944932730738Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-10
16944932730745Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-10
16944932730752Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-10
20884521050430DoverCardinal Health, Inc.EXJ2018-06-30
20884521003627DoverCardinal Health, Inc.EXJ2018-06-30
20884521007861DoverCardinal Health, Inc.EXJ2018-06-30
10884521003989DoverCardinal Health, Inc.EXJ2018-06-30
20884521003870DoverCardinal Health, Inc.EXJ2018-06-27
10884521157026DoverCardinal Health, Inc.EXJ2018-06-27