Utas
6CH Pattern/Multi-Focal Only
1manufacturer
34catalogue numbers in this listing
Who Else Makes It
Registered in Shaanxi. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
Record
| Listed by | L K C Technologies, Inc. |
|---|---|
| FDA product code | GWE |
| Device type | Stimulator, Photic, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1890 |
| Record published | 2022-02-04 |
| Record revised | 2023-12-01 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-07-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UTAS System Type-99 | In distribution | |
| UTAS System Type-50 Pattern/Multifocal | In distribution | |
| UTAS System Type-50L Pattern/Multifocal | In distribution | |
| UTAS System Type-64L | In distribution | |
| UTAS System Type-53 Pattern/Multifocal/SunBurst/RETeval | Withdrawn | |
| UTAS System Type-10L | Withdrawn | |
| UTAS System Type-72 | Withdrawn | |
| UTAS System Type-52 Pattern/Multifocal/SunBurst | Withdrawn | |
| UTAS System Type-48L | Withdrawn | |
| UTAS System Type-9 | Withdrawn | |
| UTAS System Type-35 | Withdrawn | |
| UTAS System Type-12L | Withdrawn | |
| UTAS System Type-41 | Withdrawn | |
| UTAS System Type-16 | Withdrawn | |
| UTAS System Type-9L | Withdrawn | |
| UTAS System Type-14 | Withdrawn | |
| UTAS System Type-98 | Withdrawn | |
| UTAS System Type-40 | Withdrawn | |
| UTAS System Type-52L Pattern/Multifocal/SunBurst | Withdrawn | |
| UTAS System Type-47 | Withdrawn | |
| UTAS System Type-12 | Withdrawn | |
| UTAS System Type-10 | Withdrawn | |
| UTAS System Type-47L | Withdrawn | |
| UTAS System Type-54 Dark Adapt | Withdrawn | |
| UTAS System Type-10 | Withdrawn | |
| UTAS System Type-64 | Withdrawn | |
| UTAS System Type-62 | Withdrawn | |
| UTAS System Type-11L | Withdrawn | |
| UTAS System Type-39 | Withdrawn | |
| UTAS System Type-41L | Withdrawn | |
| UTAS System Type-39L | Withdrawn | |
| UTAS System Type-62 | Withdrawn | |
| UTAS System Type-40L | Withdrawn | |
| UTAS System Type-48 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Espion | Diagnosys LLC | 129 |
| Diopsys® | Diopsys Inc. | 13 |
| Stimulator, Photic, Evoked Response | Medtronic Xomed, Inc. | 6 |
| Natus | Xltek | 4 |
| Micromed | Micromed, Inc. | 4 |
| Lifelines Photic Stimulator | Lifelines Ltd. | 2 |
| RETI-port/scan 21 gamma plus | Roland Consult Stasche & Finger GmbH | 2 |
| Sierra Summit | Cadwell Industries, Inc. | 2 |
| RETI-port/scan 21 delta plus | Roland Consult Stasche & Finger GmbH | 2 |
| Stimulator, Photic, Evoked Response | Medtronic Sofamor Danek, Inc. | 2 |
| RETI-port/scan 21 gamma | Roland Consult Stasche & Finger GmbH | 1 |
| Cascade Pro | Cadwell Industries, Inc. | 1 |
Showing 12 of 41. All products under Stimulator, Photic, Evoked Response
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.