CUSTOM ULTRASONICS, INCORPORATED

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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

Accessories, Cleaning, For Endoscope (FEB) (6) Unit, Drying (JRJ) (1)

Premarket Exempt

No Yes

Clear

Scope Assist Flushing Sink (SAFS) - FLUSHINGSINKMODELS6 Catalog Number :

Device Description : A device use to flush endoscopes.

Device Class : 2

Duns Number: 029526795

Premarket Exempt : No

Product Code : FEB

Prescription Use : No

Device Count : 1

Scope Assist Flushing Sink (SAFS) - FLUSHINGSINKMODELS8 Catalog Number :

Device Description : Device to flush endoscopes

Device Class : 2

Duns Number: 029526795

Premarket Exempt : No

Product Code : FEB

Prescription Use : No

Device Count : 1

Pre-Processing Sink - PPS83S6 Catalog Number :

Device Description : A device intended to flush endoscopes.

Device Class : 2

Duns Number: 029526795

Premarket Exempt : No

Product Code : FEB

Prescription Use : No

Device Count : 1

Pre-Processing Sink - PPS83S8 Catalog Number :

Device Description : A device intended to flush endoscopes.

Device Class : 2

Duns Number: 029526795

Premarket Exempt : No

Product Code : FEB

Prescription Use : No

Device Count : 1

Storage Cabinet - STORAGECABINET20000 Catalog Number :

Device Description : A device to store endoscopes.

Device Class : 1

Duns Number: 029526795

Premarket Exempt : Yes

Product Code : JRJ

Prescription Use : No

Device Count : 1

SYSTEM 83 PLUS - SYSTEM83PLUS2 Catalog Number :

Device Description : A device to disinfect endoscopes

Device Class :

Duns Number: 029526795

Premarket Exempt : No

Product Code : FEB

Prescription Use : No

Device Count : 1

SYSTEM 83 PLUS - SYSTEM83PLUS9 Catalog Number :

Device Description : A device to disinfect endoscopes

Device Class :

Duns Number: 029526795

Premarket Exempt : No

Product Code : FEB

Prescription Use : No

Device Count : 1

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