Catalogue number SupraFuser Generator, listed by Surgical Fusion Technologies GmbH, Switzerland, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Fujian (1).
Record
Regulatory record for SupraFuser Generator | Listed by | Surgical Fusion Technologies GmbH, Switzerland |
| FDA product code | GAT |
| Device type | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K240288 |
| Record published | 2024-04-12 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 85 % RH; Handling environment temperature 10 to 30 °C; Storage environment temperature -10 to 50 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 30 to 75 % RH |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
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.