FDA.reportPublic FDA data

Dover

Primary DI
10884521050433
Brand
Dover
Company
Cardinal Health, Inc.
Model
8884730398
Catalog number
8884730398
Device description
Texas Male External Catheter,Foam Adhesive Strap
Published
2018-06-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
20884521050430PackageGS1144Not in Commercial Distribution
10884521050433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452105043020884521050430
1088452105043310884521050433

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Regulatory Flags#

DUNS number
080935429
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
10884521000308Dover20042004-2016-09-24
10884521000681Dover202020202016-09-24
10884521001039Dover20142014-2016-09-24
10884521001053Dover20182018-2016-09-24
10884521001084Dover625662562016-09-24
10884521009455Dover34203420-2016-09-24
10884521009585Dover3450LF3450LF2016-09-24
10884521082403Curity260026002018-06-29
10884521084216Kerlix26719267192018-06-29
10884521158863Kendall2419CD2419CD2018-06-28
10884527020782Curity260126012018-06-29
10884521174917Devon31141206311412062016-09-24
10884527009954Kendall30781747307817472018-06-23
10884521015791Dover888762312588876231252016-09-24
30884527004847KendallES82417ES82417-2016-09-24
20884521152134Covidien3114574431145744-2016-09-24
30884521024841Kendall923692362018-06-30
10884521138247Devon31146891311468912016-09-24
10884521138261Devon31146893311468932016-09-24
10884521154094Devon31146894311468942016-09-24

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
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