Y/C Cable
"MB-631 Isolation Transformer"
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 23 |
Record
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | GCW |
| Device type | Transformer, Endoscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-21 |
| Record revised | 2023-06-16 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MB-631 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 123 |
| Transformer, Endoscope | Pentax of America, Inc. | 2 |
| Henry Schein | Henry Schein, Inc. | 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.