FDA.report

Dover

Primary DI
20884521050430
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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EXJDEVICE, INCONTINENCE, UROSHEATH TYPE, STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
EXJDevice, Incontinence, Urosheath Type, SterileGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20884521050430PackageGS1144In Commercial Distribution
10884521050433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088452105043020884521050430
1088452105043310884521050433

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Sterilization Methods

Method

Regulatory Flags

DUNS number
080935429
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

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10884521021105MonojectSC5008XSC5008X2016-10-20
10884521021112MonojectSC6011XSC6011X2016-10-20
20884521152066Devon31145660311456602016-09-24
20884521152073Devon31145678311456782016-09-24
20884521152080Devon31145686311456862016-09-24
20884521152097Devon31145694311456942016-09-24
20884521152103Devon31145702311457022016-09-24
20884521152110Devon31145710311457102016-09-24
20884521152127Devon31145728311457282016-09-24
20884527020529Argyle888816035888881603582016-09-28
10884521000711Argyle888875001888887500182016-09-24
10884521000735Argyle888875051388887505132016-09-24
10884521011502Kangaroo888474121288847412122016-09-24
10884521011519Kangaroo888474121588847412152016-09-24
10884521011526Kangaroo888474122088847412202016-10-20
10884521011533Kangaroo888474122588847412252016-09-24
10884521011557Kangaroo888474123588847412352016-09-24
10884521011595Kangaroo888474164988847416492016-09-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20192253030188DoverCardinal Health 200, LLCEXJ2025-04-01
50192253030028DoverCardinal Health 200, LLCEXJ2024-12-17
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
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10884521003989DoverCardinal Health, Inc.EXJ2018-06-30
20884521003870DoverCardinal Health, Inc.EXJ2018-06-27
10884521157026DoverCardinal Health, Inc.EXJ2018-06-27