RigiScan 31665

GUDID 10854759007059

Leg Strap, Disposable

GOTOP MEDICAL INC

Penile tumescence long-term ambulatory recorder transducer

• Primary Device ID: 10854759007059
• NIH Device Record Key: e1e2d486-262e-4645-8a23-7405ab6a995a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RigiScan
• Version Model Number: 31665
• Catalog Number: 31665
• Company DUNS: 045738761
• Company Name: GOTOP MEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 651-283-5125
• Email: Claire.Hovland@gotopmedical.com
• Phone: 651-283-5125
• Email: Claire.Hovland@gotopmedical.com
• Phone: 651-283-5125
• Email: Claire.Hovland@gotopmedical.com
• Phone: 651-283-5125
• Email: Claire.Hovland@gotopmedical.com
• Phone: 651-283-5125
• Email: Claire.Hovland@gotopmedical.com
• Phone: 651-283-5125
• Email: Claire.Hovland@gotopmedical.com
• Phone: 651-283-5125
• Email: Claire.Hovland@gotopmedical.com
• Phone: 651-283-5125
• Email: Claire.Hovland@gotopmedical.com
• Phone: 651-283-5125
• Email: Claire.Hovland@gotopmedical.com
• Phone: 651-283-5125
• Email: Claire.Hovland@gotopmedical.com
• Phone: 651-283-5125
• Email: Claire.Hovland@gotopmedical.com
• Phone: 651-283-5125
• Email: Claire.Hovland@gotopmedical.com
• Phone: 651-283-5125
• Email: Claire.Hovland@gotopmedical.com
• Phone: 651-283-5125
• Email: Claire.Hovland@gotopmedical.com
• Phone: 651-283-5125
• Email: Claire.Hovland@gotopmedical.com
• Phone: 651-283-5125
• Email: Claire.Hovland@gotopmedical.com
• Phone: 651-283-5125
• Email: Claire.Hovland@gotopmedical.com
• Phone: 651-283-5125
• Email: Claire.Hovland@gotopmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10854759007059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941781

FDA Product Code

• LIL: Monitor, Penile Tumescence

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-11-07
• Device Publish Date: 2017-11-01

On-Brand Devices [RigiScan]

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