GOTOP MEDICAL INC

Address:1000 Westgate Dr Ste 125,Saint Paul,MN,55114,US

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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

Monitor, Penile Tumescence (LIL) (10)

Premarket Exempt

Clear

RigiScan Plus - 00854759007007 Catalog Number : 9001

Device Description : RigiScan Plus System

Device Class : U

Duns Number: 045738761

Premarket Exempt : No

Product Code : LIL

Prescription Use : Yes

Device Count : 1

RigiScan - 00854759007014 Catalog Number : 9003

Device Description : RigiScan Monitor

Device Class : U

Duns Number: 045738761

Premarket Exempt : No

Product Code : LIL

Prescription Use : Yes

Device Count : 1

RigiScan - 00854759007021 Catalog Number : 9021

Device Description : Base Tension Guide

Device Class : U

Duns Number: 045738761

Premarket Exempt : No

Product Code : LIL

Prescription Use : Yes

Device Count : 1

RigiScan - 00854759007038 Catalog Number : 9033

Device Description : Tip Tension Guide

Device Class : U

Duns Number: 045738761

Premarket Exempt : No

Product Code : LIL

Prescription Use : Yes

Device Count : 1

RigiScan - 00854759007045 Catalog Number : 9020

Device Description : Loop Covers, Dis, 12pk

Device Class : U

Duns Number: 045738761

Premarket Exempt : No

Product Code : LIL

Prescription Use : Yes

Device Count : 1

RigiScan - 00854759007052 Catalog Number : 61597

Device Description : Dis, Leg Strap, 12 Pk

Device Class : U

Duns Number: 045738761

Premarket Exempt : No

Product Code : LIL

Prescription Use : Yes

Device Count : 1

RigiScan - 00854759007069 Catalog Number : 9030

Device Description : Leg Strap, reusable

Device Class : U

Duns Number: 045738761

Premarket Exempt : No

Product Code : LIL

Prescription Use : Yes

Device Count : 1

RigiScan - 00854759007076 Catalog Number : 9029

Device Description : Waist/Leg Strap Extender

Device Class : U

Duns Number: 045738761

Premarket Exempt : No

Product Code : LIL

Prescription Use : Yes

Device Count : 1

RigiScan - 00854759007083 Catalog Number : 606003-004

Device Description : Communication Cable

Device Class : U

Duns Number: 045738761

Premarket Exempt : No

Product Code : LIL

Prescription Use : Yes

Device Count : 1

RigiScan - 00854759007090 Catalog Number : 9034

Device Description : Flash Drive Assembly

Device Class : U

Duns Number: 045738761

Premarket Exempt : No

Product Code : LIL

Prescription Use : Yes

Device Count : 1

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