Duns Number:305164017
Catalog Number
-
Brand Name
Micro well group culture dish, 16-well
Version/Model Number
16606
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 15, 2020
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MQK
Product Code Name
Labware, Assisted Reproduction
Public Device Record Key
7b76c2a0-2d6a-44d5-99af-cf22aaecf1b9
Public Version Date
March 10, 2021
Public Version Number
5
DI Record Publish Date
June 15, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 3 |