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) (10)

Premarket Exempt

No Yes

Clear

Mui Scientific - 00678467000323 Catalog Number :

Device Description : 6-Channel Reusable Esophageal Acid Loading- Ph Study Catheter

Device Class : 2

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 1

Mui Scientific - 00678467000330 Catalog Number :

Device Description : 6-Channel Reusable Esophageal Acid Loading- Ph Study Catheter

Device Class : 2

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 1

Mui Scientific - 00678467000347 Catalog Number :

Device Description : 3-Channel Standard Reusable Anorectal Catheter with Balloon

Device Class : 2

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 1

Mui Scientific - 00678467000354 Catalog Number :

Device Description : 4-Channel Standard Reusable Anorectal Radial Catheter

Device Class : 2

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 1

Mui Scientific - 00678467000361 Catalog Number :

Device Description : 4-Channel Standard Reusable Anorectal Catheter with Balloon

Device Class : 2

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 1

Mui Scientific - 00678467000378 Catalog Number :

Device Description : 6-Channel Standard Reusable Anorectal Catheter

Device Class : 2

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 1

Mui Scientific - 00678467000385 Catalog Number :

Device Description : 6-Channel Standard Reusable Anorectal Catheter with Balloon

Device Class : 2

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 1

Mui Scientific - 00678467000392 Catalog Number :

Device Description : 8-Channel Standard Reusable Anorectal Catheter

Device Class : 2

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 1

Mui Scientific - 00678467000408 Catalog Number :

Device Description : 8-Channel Standard Reusable Anorectal Double Radial Catheter

Device Class : 2

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 1

Mui Scientific - 00678467000415 Catalog Number :

Device Description : 8-Channel Standard Reusable Anorectal Double Radial Catheter

Device Class : 2

Duns Number: 243872611

Premarket Exempt : No

Product Code : FFX

Prescription Use : No

Device Count : 1

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