Wellead Male External Catheter

GUDID 16936881133395

Type I 30mm

Well Lead Medical Co.,Ltd

Penis wearable urinal
Primary Device ID16936881133395
NIH Device Record Keyde4bad4c-27fc-4493-8fcd-de6fbf8e4895
Commercial Distribution StatusIn Commercial Distribution
Brand NameWellead Male External Catheter
Version Model NumberF03A013010
Company DUNS544811862
Company NameWell Lead Medical Co.,Ltd
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106936881133398 [Primary]
GS116936881133395 [Package]
Contains: 06936881133398
Package: Box [30 Units]
In Commercial Distribution
GS126936881133392 [Package]
Package: Carton [10 Units]
In Commercial Distribution

FDA Product Code

EXJDevice, Incontinence, Urosheath Type, Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-19
Device Publish Date2023-07-11

On-Brand Devices [Wellead Male External Catheter]

16944932730752Type III 41mm
16944932730745Type III 36mm
16944932730738Type III 32mm
16944932730721Type III 29mm
16944932730714Type III 25mm
16944932725574Type II 41mm
16936881133524Type III 30mm
16936881133500Type III 28mm
16944932725567Type II 36mm
16944932725550Type II 32mm
16944932725543Type II 29mm
16944932725536Type II 25mm
16944932725529Type I 41mm
16944932725512Type I 36mm
16944932725505Type I 32mm
16944932725499Type I 29mm
16944932725482Type I 25mm
16936881133456Type II 30mm
16936881133432Type II 28mm
16936881133395Type I 30mm
16936881133388Type I 28mm

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