Wellead Male External Catheter

GUDID 16936881133432

Penis wearable urinal

Primary Device ID	16936881133432
NIH Device Record Key	ea418cc8-4edc-4ffb-8e20-787a63693d08
Commercial Distribution Status	In Commercial Distribution
Brand Name	Wellead Male External Catheter
Version Model Number	F03A022810
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 Issuing Agency	Device ID
GS1	06936881133435 [Primary]
GS1	16936881133432 [Package] Contains: 06936881133435 Package: Box [30 Units] In Commercial Distribution
GS1	26936881133439 [Package] Package: Carton [10 Units] In Commercial Distribution

EXJ	Device, Incontinence, Urosheath Type, Sterile

Steralize Prior To Use	false
Device Is Sterile	true