RigiScan 61597
GUDID 00854759007052
Dis, Leg Strap, 12 Pk
GOTOP MEDICAL INC
Penile tumescence long-term ambulatory recorder transducer| Primary Device ID | 00854759007052 |
| NIH Device Record Key | d7cdc376-6e7f-4649-b7b8-af78ad31e90f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RigiScan |
| Version Model Number | 61597 |
| Catalog Number | 61597 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854759007052 [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 | 2 |
| Public Version Date | 2018-03-29 |
| 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. |
Trademark Results [RigiScan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RIGISCAN 73476590 1320535 Live/Registered |
Dacomed Corporation 1984-04-23 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.