Duns Number:118793157
Catalog Number
-
Brand Name
MEM Earles
Version/Model Number
51200038
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 29, 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
b6f8401f-ae19-4204-9421-e12c6fb5f2e0
Public Version Date
May 09, 2022
Public Version Number
4
DI Record Publish Date
August 01, 2016
Package DI Number
30190302004705
Quantity per Package
10
Contains DI Package
10190302004701
Package Discontinue Date
April 28, 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 |