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) (5)

Premarket Exempt

No Yes

Clear

Mui Scientific - 10678467507850 Catalog Number :

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

Device Class : 2

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 10

Mui Scientific - 10678467507867 Catalog Number :

Device Description : 12-Channel Customized Single-Use Anorectal Catheter

Device Class : 2

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 10

Mui Scientific - 10678467507898 Catalog Number :

Device Description : Customized Single-Use Barostat Catheter (with 150mL Balloon)

Device Class : 2

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 10

Mui Scientific - 10678467507904 Catalog Number :

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

Device Class : 2

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 10

Mui Scientific - 10678467507911 Catalog Number :

Device Description : 8-Channel Customized Single-Use Pediatric Antroduodenal Catheter

Device Class : 2

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 10

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