RigiScan

Basic Information

• Brand Name: RigiScan
• Primary DI: 00854759007052
• Version / Model: 61597
• Catalog Number: 61597
• 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: 3
• Public Version Date: 2022-11-07
• Public Version Status: Update
• Public Device Record Key: d7cdc376-6e7f-4649-b7b8-af78ad31e90f

Device Description

Dis, Leg Strap, 12 Pk

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• 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
17442	Penile tumescence long-term ambulatory recorder transducer	A device intended to be used together with a parent device (e.g., a penile tumescence long-term trend recorder) to detect the swelling of the penis and provide the electronic signals of the physiological changes which are processesed and displayed as measurements by the parent device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854759007052	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K941781	000