Duns Number:373904101
Device Description: Sil-Select Stock with gentamicin - SIS100_32G (100 ml) Sil-Select Stock™ is a solution of Sil-Select Stock with gentamicin - SIS100_32G (100 ml) Sil-Select Stock™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Stock has a 18 month shelf life from date of manufacturer For the latest version of the intructions for use and MSDS, visit our product page on the FertiPro's website (www.fertipro.com)
Catalog Number
-
Brand Name
Sil-Select Stock with gentamicin
Version/Model Number
SIS100G (100ml with gentamicin)
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 19, 2016
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
d03811db-8063-46a9-873b-7c9880bc2d4e
Public Version Date
May 06, 2022
Public Version Number
4
DI Record Publish Date
September 19, 2016
Package DI Number
05411967000654
Quantity per Package
1
Contains DI Package
54119670012860
Package Discontinue Date
September 19, 2016
Package Status
Not in Commercial Distribution
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 |