Duns Number:373904101
Device Description: Sil-Select Plus™Sperm preparation mediaSil-Select Plus™ is our home made new and improved Sil-Select Plus™Sperm preparation mediaSil-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
Catalog Number
-
Brand Name
Sil-Select Plus Lower Layer
Version/Model Number
SIP100LO_AF (100ml)
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 02, 2018
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
c75587bd-2360-4681-b5da-73aefa22d1e4
Public Version Date
September 03, 2018
Public Version Number
1
DI Record Publish Date
August 02, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |