GM501 Gradient 100% is a stock solution for semen preparation. It is a ready-to-use isotonic gradient for semen preparation with a density of approximately 1.12g/ml. GM501 Gradient 100% can…
GM501 Gradient 100% is a stock solution for semen preparation. It is a ready-to-use isotonic gradient for semen preparation with a density of approximately 1.12g/ml. GM501 Gradient 100% can be used in combination with IUI, IVF, and ICSI procedures.
Who Else Makes It
Concentrated in Guangdong (3), Shandong (1).
Record
Regulatory record for GM501 Gradient 100% | Listed by | Hamilton Thorne, Inc., United States |
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K053494 |
| Record published | 2021-04-30 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
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.