| Primary Device ID | 00854759007007 |
| NIH Device Record Key | b8ed8e32-b4af-4661-b491-9ed85055da76 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RigiScan Plus |
| Version Model Number | 9001 |
| Catalog Number | 9001 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854759007007 [Primary] |
| LIL | Monitor, Penile Tumescence |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2017-11-01 |
| 10854759007042 - RigiScan | 2022-11-07 Disposable Loop Covers, 1 pr. |
| 10854759007059 - RigiScan | 2022-11-07 Leg Strap, Disposable |
| 00854759007007 - RigiScan Plus | 2019-11-08RigiScan Plus System |
| 00854759007007 - RigiScan Plus | 2019-11-08 RigiScan Plus System |
| 00854759007014 - RigiScan | 2019-11-08 RigiScan Monitor |
| 00854759007083 - RigiScan | 2019-11-08 Communication Cable |
| 00854759007090 - RigiScan | 2019-11-08 Flash Drive Assembly |
| 00854759007106 - RigiScan | 2019-11-08 Event Marker Switch, RigiScan |
| 00854759007021 - RigiScan | 2018-03-29 Base Tension Guide |