All Silicone Foley Catheter

GUDID 16944932754321

2-way Female 12Fr5-10ml

Well Lead Medical Co.,Ltd

Indwelling urethral drainage balloon catheter, non-antimicrobial
Primary Device ID16944932754321
NIH Device Record Key09e4560f-4d6b-4683-8a1b-aa2061c58e14
Commercial Distribution StatusIn Commercial Distribution
Brand NameAll Silicone Foley Catheter
Version Model NumberF01B031205
Company DUNS544811862
Company NameWell Lead Medical Co.,Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS106944932754324 [Primary]
GS116944932754321 [Package]
Contains: 06944932754324
Package: Box [10 Units]
In Commercial Distribution
GS126944932754328 [Package]
Package: Carton [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZLCatheter, Retention Type, Balloon

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-27
Device Publish Date2024-05-17

On-Brand Devices [All Silicone Foley Catheter]

169449327554583-way Standard 26Fr30ml
169449327554413-way Standard 26Fr15ml
169449327554343-way Standard 26Fr10ml
169449327554273-way Standard 26Fr5-15ml
169449327554103-way Standard 26Fr5-10ml
169449327553973-way Standard 24Fr30ml
169449327553803-way Standard 24Fr15ml
169449327553733-way Standard 24Fr10ml
169449327553663-way Standard 24Fr5-15ml
169449327553423-way Standard 24Fr5-10ml
169449327553283-way Standard 22Fr30ml
169449327553113-way Standard 22Fr15ml
169449327553043-way Standard 22Fr10ml
169449327552983-way Standard 22Fr5-15ml
169449327552813-way Standard 22Fr5-10ml
169449327552673-way Standard 20Fr30ml
169449327552503-way Standard 20Fr15ml
169449327552433-way Standard 20Fr10ml
169449327552363-way Standard 20Fr5-15ml
169449327552293-way Standard 20Fr5-10ml
169449327552053-way Standard 18Fr30ml
169449327551993-way Standard 18Fr15ml
169449327551823-way Standard 18Fr10ml
169449327551753-way Standard 18Fr5-15ml
169449327551683-way Standard 18Fr5-10ml
169449327551443-way Standard 16Fr30ml
169449327551373-way Standard 16Fr15ml
169449327551203-way Standard 16Fr10ml
169449327551133-way Standard 16Fr5-15ml
169449327551063-way Standard 16Fr5-10ml
169449327543832-way Female 14Fr10ml
169449327543762-way Female 14Fr5-15ml
169449327543692-way Female 14Fr5-10ml
169449327543452-way Female 12Fr10ml
169449327543382-way Female 12Fr5-15ml
169449327543212-way Female 12Fr5-10ml
169449327540002-way Standard 26Fr30ml
169449327539972-way Standard 26Fr10ml
169449327539802-way Standard 26Fr5-15ml
169449327539732-way Standard 26Fr5-10ml
169449327539662-way Standard 26Fr5ml
169449327539422-way Standard 24Fr30ml
169449327539282-way Standard 24Fr15ml
169449327539112-way Standard 24Fr10ml
169449327539042-way Standard 24Fr5-15ml
169449327538982-way Standard 24Fr5-10ml
169449327538812-way Standard 24Fr5ml
169449327538672-way Standard 22Fr30ml
169449327538432-way Standard 22Fr15ml
169449327538362-way Standard 22Fr10ml

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.