FDA.reportPublic FDA data

Wellead Hydrophilic Intermittent Catheter

Primary DI
06925816674136
Brand
Wellead Hydrophilic Intermittent Catheter
Company
Well Lead Medical Co.,Ltd
Model
F01L010810
Device description
Compact Female 8Fr
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
16925816674133PackageGS130In Commercial Distribution
26925816674130PackageGS110In Commercial Distribution
06925816674136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1692581667413316925816674133
2692581667413026925816674130
06925816674136069258166741366925816674136

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
06925816674044Wellead Hydrophilic Intermittent Catheter F01L0212202026-04-03
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
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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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