Wellead Male External Catheter

GUDID 16944932730738

Type III 32mm

Well Lead Medical Co.,Ltd

Penis wearable urinal Penis wearable urinal Penis wearable urinal Penis wearable urinal Penis wearable urinal Penis wearable urinal Penis wearable urinal Penis wearable urinal Penis wearable urinal Penis wearable urinal Penis wearable urinal Penis wearable urinal Penis wearable urinal Penis wearable urinal Penis wearable urinal Penis wearable urinal Penis wearable urinal

• Primary Device ID: 16944932730738
• NIH Device Record Key: df28c295-81b6-4e8e-bf9b-6794ce30f5a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wellead Male External Catheter
• Version Model Number: F03A033210
• Company DUNS: 544811862
• Company Name: Well Lead Medical Co.,Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944932730731 [Primary]
GS1	16944932730738 [Package]; Contains: 06944932730731; Package: Box [30 Units]; In Commercial Distribution
GS1	26944932730735 [Package]; Package: Carton [10 Units]; In Commercial Distribution

FDA Product Code

• EXJ: Device, Incontinence, Urosheath Type, Sterile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-18
• Device Publish Date: 2023-07-10

On-Brand Devices [Wellead Male External Catheter]

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