RigiScan 606003-004

GUDID 00854759007083

Communication Cable

GOTOP MEDICAL INC

Penile tumescence ambulatory recorder
Primary Device ID00854759007083
NIH Device Record Keyb8825973-411b-4a69-a4c9-a22dc2bf718e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRigiScan
Version Model Number606003-004
Catalog Number606003-004
Company DUNS045738761
Company NameGOTOP MEDICAL INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com
Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com
Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com
Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com
Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com
Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com
Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com
Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com
Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com
Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com
Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com
Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com
Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com
Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com
Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com
Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com
Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com
Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com
Phone651-283-5125
EmailClaire.Hovland@gotopmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854759007083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LILMonitor, Penile Tumescence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-08
Device Publish Date2017-11-01

On-Brand Devices [RigiScan]

00854759007106Event Marker Switch, RigiScan
00854759007090Flash Drive Assembly
00854759007083Communication Cable
00854759007076Waist/Leg Strap Extender
00854759007069Leg Strap, reusable
00854759007052Dis, Leg Strap, 12 Pk
00854759007045Loop Covers, Dis, 12pk
00854759007038Tip Tension Guide
00854759007021Base Tension Guide
00854759007014RigiScan Monitor
10854759007059Leg Strap, Disposable
10854759007042Disposable Loop Covers, 1 pr.

Trademark Results [RigiScan]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RIGISCAN
RIGISCAN
73476590 1320535 Live/Registered
Dacomed Corporation
1984-04-23

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