FDA.reportPublic FDA data

Wellead Hydrophilic Intermittent Catheter

Primary DI
06925816674044
Brand
Wellead Hydrophilic Intermittent Catheter
Company
Well Lead Medical Co.,Ltd
Model
F01L021220
Device description
Ready to use Female 12Fr
Published
2026-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EZDCatheter, Straight

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZDCatheter, StraightGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241734000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241734000Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.2025-03-05GBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16925816674041PackageGS130In Commercial Distribution
26925816674048PackageGS110In Commercial Distribution
06925816674044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1692581667404116925816674041
2692581667404826925816674048
06925816674044069258166740446925816674044

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent urethral drainage catheter, non-antimicrobial, single-useA flexible or rigid tube designed for a single insertion into the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide urine drainage, typically for an individual who is physiologically incapable of voiding. The device is typically pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass] and is disposed of after use; it does not include an antimicrobial agent(s). The device may be male or female dedicated. This is a single-use device.

Regulatory Flags#

DUNS number
544811862
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06925816673962Wellead Hydrophilic Intermittent Catheter F01L0308302026-04-03
06925816673979Wellead Hydrophilic Intermittent Catheter F01L0310302026-04-03
06925816673986Wellead Hydrophilic Intermittent Catheter F01L0312302026-04-03
06925816673993Wellead Hydrophilic Intermittent Catheter F01L0314302026-04-03
06925816674006Wellead Hydrophilic Intermittent Catheter F01L0316302026-04-03
06925816674013Wellead Hydrophilic Intermittent Catheter F01L0318302026-04-03
06925816674020Wellead Hydrophilic Intermittent Catheter F01L0208202026-04-03
06925816674037Wellead Hydrophilic Intermittent Catheter F01L0210202026-04-03
06925816674051Wellead Hydrophilic Intermittent Catheter F01L0214202026-04-03
06925816674068Wellead Hydrophilic Intermittent Catheter F01L0216202026-04-03
06925816674075Wellead Hydrophilic Intermittent Catheter F01L0218202026-04-03
06925816674082Wellead Hydrophilic Intermittent Catheter F01L0410302026-04-03
06925816674099Wellead Hydrophilic Intermittent Catheter F01L0412302026-04-03
06925816674105Wellead Hydrophilic Intermittent Catheter F01L0414302026-04-03
06925816674112Wellead Hydrophilic Intermittent Catheter F01L0416302026-04-03
06925816674129Wellead Hydrophilic Intermittent Catheter F01L0418302026-04-03
06925816674136Wellead Hydrophilic Intermittent Catheter F01L0108102026-04-03
06925816674143Wellead Hydrophilic Intermittent Catheter F01L0110102026-04-03
06925816674150Wellead Hydrophilic Intermittent Catheter F01L0112102026-04-03
06925816674167Wellead Hydrophilic Intermittent Catheter F01L0114102026-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10197344162284MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
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10704411008835AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
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10704411008880AMSure®HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02