Amsco
The 3080-R Remanufactured Table is a general operating table that can handle a variety of surgical specialties including urology, neurology, pediatrics, ENT and endovascular procedures.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Sintang Health&Technology Co., Ltd. | Yancheng | Jiangsu | Manufacturer | 21 |
Record
| Listed by | Steris Corporation, United States |
|---|---|
| FDA product code | FWW |
| Device type | Table, Operating-Room, Pneumatic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4960 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K930493 |
| Record published | 2021-08-05 |
| Record revised | 2023-07-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2023-07-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3080-R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Atec A.R.M. | Alphatec Spine, Inc. | 8 |
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.