FDA.report

Wellead Urethral Dilator

Primary DI
16936881136471
Brand
Wellead Urethral Dilator
Company
Well Lead Medical Co.,Ltd
Model
U02A082610
Device description
Urethral Dilator Straight, Hydrophilic coated 26Fr
Published
2023-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KOEDilator, Urethral

Product Code Classifications

CodeDeviceSpecialtyClass
KOEDilator, UrethralGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16936881136471PackageGS15In Commercial Distribution
26936881136478PackageGS110In Commercial Distribution
06936881136474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1693688113647116936881136471
2693688113647826936881136478
06936881136474069368811364746936881136474

GMDN Terms

TermDefinition
Urethral dilator, single-useA slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typically made of metal or plastics and is available in a range of sizes; it may include a mechanical expanding mechanism. The device may also include a dial to show the degree of expansion of the urethra and as such is usually considered a urethrometer. Urethral bougies are also used for urethral dilatation. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
544811862
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
16925816667210ClearPetraU04A1010262026-03-16
16925816667227ClearPetraU04A1011262026-03-16
16925816667234ClearPetraU04A1012262026-03-16
16925816657518ClearPetraU04A1010262026-01-26
16925816657525ClearPetraU04A1011262026-01-26
16925816657532ClearPetraU04A1012262026-01-26
16925816657549ClearPetraU04A1013262026-01-26
16925816657556ClearPetraU04A1010362026-01-26
16925816657563ClearPetraU04A1011362026-01-26
16925816657570ClearPetraU04A1012362026-01-26
16925816657587ClearPetraU04A1013362026-01-26
16925816657594ClearPetraU04A1010402026-01-26
16925816657600ClearPetraU04A1011402026-01-26
16925816657617ClearPetraU04A1012402026-01-26
16925816657624ClearPetraU04A1013402026-01-26
16925816657631ClearPetraU04A1010462026-01-26
16925816657648ClearPetraU04A1011462026-01-26
16925816657655ClearPetraU04A1012462026-01-26
16925816657662ClearPetraU04A1013462026-01-26
16925816657679ClearPetraU04A1010502026-01-26

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00853095008372Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008389Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008396Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
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00856877002704Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2024-08-06
06936534328683Single Use Urethral DilatorZhejiang Chuangxiang Medical Technology Co., LTD.KOE2023-10-24
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16936881136402Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136419Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
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16936881136433Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136440Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136457Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
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16936881102520Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-10
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00856877002728QL Disposable Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2022-11-07
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