Duns Number:118793157
Catalog Number
-
Brand Name
MEM Earles
Version/Model Number
11095072
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 18, 2022
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
f810ca79-d688-4ed7-9fe1-399c43cf1cdb
Public Version Date
May 23, 2022
Public Version Number
4
DI Record Publish Date
August 01, 2016
Package DI Number
30190302001667
Quantity per Package
6
Contains DI Package
10190302001663
Package Discontinue Date
May 18, 2022
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 |