ESI CORPORATION

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) (7) Stopcock, I.V. Set (FMG) (2) Device, Irrigation, Ocular Surgery (KYG) (1)

Premarket Exempt

No Yes

Clear

Prager Ext Set A1236 - B360011B12360 Catalog Number : 011B1236

Device Description : Replacement Part

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : FMG

Prescription Use : Yes

Device Count : 1

Prager Ext Set B1263 - B360011B12630 Catalog Number : 011B1263

Device Description : Replacement Part

Device Class :

Duns Number: 829391734

Premarket Exempt : No

Product Code : FMG

Prescription Use : Yes

Device Count : 1

ClearScan® - B360CS2000 Catalog Number : CS200

Device Description : ClearScan

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Kera-Flow - B360KF100 Catalog Number : KF100

Device Description : Eye Irrigation Device

Device Class :

Duns Number: 829391734

Premarket Exempt : Yes

Product Code : KYG

Prescription Use : No

Device Count : 1

Prager Shell® - B360P1000 Catalog Number : P-100

Device Description : Accutome / MicroMedical

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Prager Shell® - B360P100AS0 Catalog Number : P-100-AS

Device Description : Accutome Probe, Auto Stop

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Prager Shell® - B360P1010 Catalog Number : P-101

Device Description : For DGH 2009 and earlier

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Prager Shell® - B360P10120 Catalog Number : P-101-2

Device Description : For DGH 2010 and later

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Prager Shell® - B360P1020 Catalog Number : P-102

Device Description : Tomey AL 100

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Prager Shell® - B360P10220 Catalog Number : P-102-2

Device Description : Tomey AL 4000

Device Class : 2

Duns Number: 829391734

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

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