FDA.reportPublic FDA data

Dover

Primary DI
50192253030097
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
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
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.

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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

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
10192253030099DoverCardinal Health 200, LLCEXJ2024-12-17
50192253030028DoverCardinal 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