Uroplasty, Inc.

Address:5420 FELTL ROAD,Minnetonka,MN,55343,US

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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

Endoscopic Injection Needle, Gastroenterology-Urology (FBK) (2) Stimulator,Peripheral Nerve,Non-Implanted,For Pelvic Floor Dysfunction (NAM) (2) Agent, Bulking, Injectable For Gastro-Urology Use (LNM) (1)

Premarket Exempt

Clear

Urgent® PC Neuromodulation System - 08717591240167 Catalog Number : UPC 250

Device Description : Lead Set

Device Class : 2

Duns Number: 804002665

Premarket Exempt : No

Product Code : NAM

Prescription Use : No

Device Count : 1

Urgent® PC Neuromodulation System - 08717591240228 Catalog Number : UPC 200

Device Description : Stimulator

Device Class : 2

Duns Number: 804002665

Premarket Exempt : No

Product Code : NAM

Prescription Use : No

Device Count : 1

Macroplastique Implants - 08717591240266 Catalog Number : MPQ-2.5

Device Description : Soft tissue bulking agent indicated for transurethral injection in the treatment Soft tissue bulking agent indicated for transurethral injection in the treatment of adult women diagnosed with stress urinary incontinence primarily due to intrinsic sphincter deficiency.

Device Class : 3

Duns Number: 804002665

Premarket Exempt : No

Product Code : LNM

Prescription Use : Yes

Device Count : 1

Rigid Endoscopic Needle - 08717591240273 Catalog Number : MRN-518

Device Class : 2

Duns Number: 804002665

Premarket Exempt : No

Product Code : FBK

Prescription Use : No

Device Count : 1

Rigid Endoscopic Needle - 08717591240280 Catalog Number : MRN-420

Device Class : 2

Duns Number: 804002665

Premarket Exempt : No

Product Code : FBK

Prescription Use : No

Device Count : 1

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