MED-SONICS 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

Lithotriptor, Electro-Hydraulic (FFK) (10)

Premarket Exempt

Clear

UreTron Generator - 00854732006003 Catalog Number :

Device Description : UreTron Lithotripter Generator

Device Class : 2

Duns Number: 009836084

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

UreTron Rigid Hand Piece - 00854732006010 Catalog Number :

Device Description : UreTron Rigid Hand Piece

Device Class : 2

Duns Number: 009836084

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

UreTron Flex Hand Piece - 00854732006027 Catalog Number :

Device Description : UreTron Flex Hand piece for Flex and Semi Flex Probes

Device Class : 2

Duns Number: 009836084

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

UreTron Rigid Sterile Probe 3.1 x 370mm - 00854732006034 Catalog Number :

Device Description : UreTron Rigid Sterile Probe 3.1 x 370mm

Device Class : 2

Duns Number: 009836084

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

UreTron Rigid Sterile Probe 3.5 x 370 mm - 00854732006041 Catalog Number :

Device Description : UreTron Rigid Sterile Probe 3.5 x 370 mm

Device Class : 2

Duns Number: 009836084

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

UreTron Rigid Sterile Probe 3.5 x 430mm - 00854732006058 Catalog Number :

Device Description : UreTron Rigid Sterile Probe 3.5 x 430mm

Device Class : 2

Duns Number: 009836084

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

UreTron Rigid Sterile Probe 3.1 x 430 mm - 00854732006065 Catalog Number :

Device Description : UreTron Rigid Sterile Probe 3.1 x 430 mm

Device Class : 2

Duns Number: 009836084

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

UreTron Semi Rigid Sterile Probe 1.9 x 370 mm - 00854732006072 Catalog Number :

Device Description : UreTron Semi Rigid Sterile Probe 1.9 x 370 mm

Device Class : 2

Duns Number: 009836084

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

UreTron Semi Rigid Sterile Probe 1.9 x 570 mm - 00854732006089 Catalog Number :

Device Description : UreTron Semi Rigid Sterile Probe 1.9 x 570 mm

Device Class : 2

Duns Number: 009836084

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

UreTron Semi Rigid Sterile Probe 1.5 x 270 mm - 00854732006096 Catalog Number :

Device Description : UreTron Semi Rigid Sterile Probe 1.5 x 270 mm

Device Class : 2

Duns Number: 009836084

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

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