Graft Cleaning Bowl
Graft cleaning bowl used in the cleaning of follicles removed from the donor area before they are entered into the recipient area.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
Record
| Listed by | Cole Instruments, United States |
|---|---|
| FDA product code | IDX |
| Device type | Sieves, Tissue |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3010 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-12-14 |
| Record revised | 2023-07-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Graft Cleaning Bowl | In distribution |
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.