RigiScan

Basic Information

• Brand Name: RigiScan
• Primary DI: 00854759007014
• Version / Model: 9003
• Catalog Number: 9003
• Company Name: GOTOP MEDICAL INC
• Labeler DUNS: 045738761
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-01
• Public Version: 4
• Public Version Date: 2022-11-07
• Public Version Status: Update
• Public Device Record Key: e8d1651c-20f1-4791-aaf5-94b44318e41a

Device Description

RigiScan Monitor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LIL	Monitor, Penile Tumescence	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
33890	Penile tumescence ambulatory recorder	An electrically-powered device intended for 24-hour recording of the tumescence (tendency to swell) of the penis. The patient is connected to and wears the device while he performs normal daily activities and is used to register the plethysmographic measurement or function of the penile erection, e.g., length, circumference, duration of the erection. The measurements are made by, e.g., a plethysmographic sleeve or a transducer placed on the penis and the data is recorded by this device and later used by the physician for the diagnosis of penile dysfunction, e.g., impotence.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854759007014	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K941781	000