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) (10)

Premarket Exempt

No Yes

Clear

Prager Shell® - B360P1030 Catalog Number : P-103

Device Description : Sonomed

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Prager Shell® - B360P103GS0 Catalog Number : P-103GS

Device Description : Sonomed, Autoclavable

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Prager Shell® - B360P103SV0 Catalog Number : P-103SV

Device Description : Sonomed

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Prager Shell® - B360P1040 Catalog Number : P-104

Device Description : Quantel Medical

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Prager Shell® - B360P104GS0 Catalog Number : P-104GS

Device Description : Quantel Medical, Autoclavable Gold Series

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Prager Shell® - B360P104SV0 Catalog Number : P-104SV

Device Description : Quantel Medical

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Prager Shell® - B360P1050 Catalog Number : P-105

Device Description : Alcon OcuScan

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Prager Shell® - B360P1060 Catalog Number : P-106

Device Description : Ellex

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Prager Shell® - B360P106GS0 Catalog Number : P-106GS

Device Description : Ellex, Autoclavable Gold Series

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Prager Shell® - B360P106SV0 Catalog Number : P-106SV

Device Description : Ellex

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

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