Sil-Select Plus™ Sperm preparation media Sil-Select Plus™ is our home made new and improved gradient system for semen preparation. Sil-Select Plus™ is a solution of silane-coated sicila…
Sil-Select Plus™ Sperm preparation media Sil-Select Plus™ is our home made new and improved gradient system for semen preparation. Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Extensive testing during the design of the product has shown it to be non-cytotoxic and non-irritant with a non-significant allergenic potential. Sil-Select Plus™ is produced from raw colloidal silica, so we have full control over each step in the production process. We have developed a very accurate purification system which results in a very clean product with endotoxin levels below 0.25EU/ml (typically below 0.1EU/ml). We now also offer Sil-Select Plus in an 80% dilution for use in IVF procedures. Sil-Select Plus has a 18 month shelf life from date of produce. Sil-Select Plus™ is CE marked as a medical device according to the Medical Device Directive 93/42/EEC. For the latest version of the intructions for use and MSDS, visit our product page on the FertiPro’s website:
Who Else Makes It
Concentrated in Guangdong (3), Shandong (1).
Record
Regulatory record for Sil-Select Plus Lower Layer | Listed by | Fertipro NV, Belgium |
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| 510(k) | K053494 |
| Record published | 2016-09-19 |
| Record revised | 2024-06-24 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2018-08-02 |
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.