ESI CORPORATION

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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

Transducer, Ultrasonic, Diagnostic (ITX) (3)

Premarket Exempt

No Yes

Clear

Prager Shell® - B360P10720 Catalog Number : P-107-2

Device Description : Nidek

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Prager Shell® - B360P110RXP0 Catalog Number : P-110RXP

Device Description : Alcon RXP OcuScan and UltraScan

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

PRAGER SHELL® P106SVGS - B360PSVGS0 Catalog Number :

Device Description : PRAGER SHELL® P106 AUTOCLAVABLE ULTRASOUND IMMERSION SHELL.

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

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