PERCUVISION LLC

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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

Catheter, Retention Type, Balloon (EZL) (2) Urethroscope (FGC) (2)

Premarket Exempt

Clear

DirectVision - 00855308006007 Catalog Number :

Device Description : 14 Fr. Coude tip catheter for DirectVision system

Device Class : 2

Duns Number: 015755434

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

DirectVision - 00855308006014 Catalog Number :

Device Description : 18 Fr. Coude tip Foley catheter for DirectVision System

Device Class : 2

Duns Number: 015755434

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

DirectVision - 00855308006021 Catalog Number :

Device Description : DirectVision Slimline System

Device Class : 2

Duns Number: 015755434

Premarket Exempt : No

Product Code : FGC

Prescription Use : No

Device Count : 1

DirectVision - 00855308006038 Catalog Number :

Device Description : DirectVision Visual Guide

Device Class : 2

Duns Number: 015755434

Premarket Exempt : No

Product Code : FGC

Prescription Use : No

Device Count : 1

DirectVision - 00855308006045 Catalog Number :

Device Description : DirectVision Catheterization Kit

Device Class :

Duns Number: 015755434

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

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