H & A Mui Enterprises Inc

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Gastrointestinal Motility (Electrical) (FFX) (9) Endoscopic Access Overtube, Gastroenterology-Urology (FED) (1)

Premarket Exempt

No Yes

Clear

Mui Scientific - 10678467506648 Catalog Number :

Device Description : 5-Channel Customized Single-Use Aspiration Catheter

Device Class :

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 10

Mui Scientific - 10678467506969 Catalog Number :

Device Description : Customized Single Use Aspiration 4 CH Catheter

Device Class :

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 10

Mui Scientific - 10678467507010 Catalog Number :

Device Description : 24-Channel Customized Single-Use HRM Anorectal Catheter

Device Class :

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 10

Muiscientific - 10678467507027 Catalog Number :

Device Description : Customized Single-Use Esophageal Barostat Catheter

Device Class :

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 10

Mui Scientific - 10678467507041 Catalog Number :

Device Description : 20-Channel Customized Single-Use HRM Esophageal Catheter

Device Class :

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 10

Mui Scientific - 10678467507065 Catalog Number :

Device Description : PatCom Single Use Introducer (ID:4.0mm OD:5.0mm)

Device Class : 2

Duns Number: 243872611

Premarket Exempt : No

Product Code : FED

Prescription Use : No

Device Count : 10

Mui Scientific - 10678467507119 Catalog Number :

Device Description : 24-Channel Customized Single-Use Colonic Catheter

Device Class :

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 10

Mui Scientific - 10678467507249 Catalog Number :

Device Description : 1-Channel Customized Single-Use Anorectal Catheter

Device Class :

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 10

Mui Scientific - 10678467507348 Catalog Number :

Device Description : Customized Single Use Esophageal Barostat Catheter

Device Class : 2

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 10

Mui Scientific - 10678467507379 Catalog Number :

Device Description : Customized Single Use HRM Esophageal 24th Catheter

Device Class : 2

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 10

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