Sil-Select Plus Lower Layer
Basic Information
- Brand Name
- Sil-Select Plus Lower Layer
- Primary DI
- 54119670011634
- Version / Model
- SIP100LO_AF (100ml)
- Company Name
- Fertipro NV
- Labeler DUNS
- 373904101
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-02
- Public Version
- 1
- Public Version Date
- 2018-09-03
- Public Version Status
- New
- Public Device Record Key
- c75587bd-2360-4681-b5da-73aefa22d1e4
- Distribution End Date
- 2018-08-02
Device Description
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: http://fertipro.com/index.php?page=media&sub=sip
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQL | Media, Reproductive | Obstetrics/Gynecology | 884.6180 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44046 | IVF medium | A solution that provides a physiological environment for the retrieval, culture, maintenance, transfer, and/or storage of human sperm, harvested oocytes (eggs), and/or resulting embryos associated with the method of in vitro fertilization (IVF). The solution typically contains various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 54119670011634 | GS1 |
Customer Contacts
- Phone
- +3250791805
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius