FDA.reportPublic FDA data

Dover

Primary DI
10192253030099
Brand
Dover
Company
Cardinal Health 200, LLC
Model
8884732398
Catalog number
8884732398
Device description
MALE EXTERNAL CATHETER, SOFT SHEATH
Published
2024-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
50192253030097PackageGS1144In Commercial Distribution
10192253030099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225303009750192253030097
1019225303009910192253030099

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.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521022683Monoject85121851212016-09-24
10884521023437Monoject890689062019-07-19
30884521018444Monoject8990Y8990Y2017-01-06
40884521018298Monoject89671896712016-09-24
40884521018380Monoject8970Y8970Y2017-01-06
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253030181DoverCardinal Health 200, LLCEXJ2025-04-01
20192253030188DoverCardinal Health 200, LLCEXJ2025-04-01
10192253030020DoverCardinal Health 200, LLCEXJ2024-12-17
50192253030028DoverCardinal Health 200, LLCEXJ2024-12-17
50192253030097DoverCardinal Health 200, LLCEXJ2024-12-17
10192253030037DoverCardinal Health 200, LLCEXJ2024-10-15
50192253030035DoverCardinal Health 200, LLCEXJ2024-10-15
06936881133381Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06936881133398Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06936881133435Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06936881133459Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06944932725485Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06944932725492Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06944932725508Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06944932725515Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06944932725522Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06944932725539Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06944932725546Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06944932725553Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
06944932725560Wellead Male External CatheterWell Lead Medical Co.,LtdEXJ2023-07-11
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