Marco
2 catalogue numbers from MARCO ENCORE MANUAL CHAIR, listed by Takagi Seiko Co., Ltd., Japan, under Chair, Ophthalmic, Manual. 1 manufacturer in China is registered for this product code.
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
Record
| Listed by | Takagi Seiko Co., Ltd., Japan |
|---|---|
| FDA product code | HMD |
| Device type | Chair, Ophthalmic, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1140 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-04-25 |
| Record revised | 2018-10-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment humidity 30 to 90 % RH; Handling environment atmospheric pressure 80 to 106 KiloPascal; Handling environment temperature 10 to 35 °C |
| Distribution end date | 2018-10-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MARCO ENCORE MANUAL CHAIR | In distribution | |
| MARCO ENCORE MANUAL CHAIR | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Reliance | Haag-Streit USA, Inc. | 11 |
| Haag-Streit Surgical | Haag-Streit USA, Inc. | 1 |
| Carl Mechanical | Rini Ergoteknik AB | 1 |
| Catalys Patient Chair | Johnson & Johnson Surgical Vision, Inc. | 1 |
| Carl | Rini Ergoteknik AB | 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.