Small Tray
"OCS5-TYS OCS-500 Small Tray"
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Guangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou | Guangxi | Manufacturer | 8 |
| Shenzhen Goldcare Meditech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | PTZ |
| Device type | Colposcope (And Colpomicroscope), Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1630 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-21 |
| Record revised | 2024-07-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-07-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OCS5-TYS | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optomic | Optomic España SA | 5 |
| UHD series Video Colposcope | Edan Instruments, Inc. | 4 |
| zumax | Zumax Medical Co., Ltd. | 2 |
| Atmos | Atmos Medizintechnik Gmbh & Co. KG | 2 |
| Video Colposcope | Edan Instruments, Inc. | 1 |
| Light guide | Olympus Medical Systems Corp. | 1 |
| Colposcope OCS-500 Digital Camera Adapter | Olympus Medical Systems Corp. | 1 |
| Colposcope OCS-500 System Rack | Olympus Medical Systems Corp. | 1 |
| Liger Medical | Liger Medical | 1 |
| Eyepiece shape TV mount | Olympus Medical Systems Corp. | 1 |
| Cerviray | Aidot | 1 |
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.