Duns Number:118793157
Catalog Number
-
Brand Name
L-Glutamine
Version/Model Number
25030081
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 17, 2019
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
KIT
Product Code Name
MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE
Public Device Record Key
d3d5404a-d8e6-4dd3-bc81-ac48a4f0657c
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
August 01, 2016
Package DI Number
30190302003913
Quantity per Package
20
Contains DI Package
10190302003919
Package Discontinue Date
October 16, 2019
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 634 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 77 |
| 3 | A medical device with high risk that requires premarket approval | 12 |