Duns Number:001307735
Device Description: Corning CellSTACK-2, Meissner Filter, TCT, PS, S, 1/bag, 8/c
Catalog Number
8213
Brand Name
Corning
Version/Model Number
8213
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
KJA
Product Code Name
Flask, tissue culture
Public Device Record Key
3971be14-d285-45fd-88d5-0141d62602fe
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
December 02, 2020
Package DI Number
H10882133
Quantity per Package
8
Contains DI Package
H10882131
Package Discontinue Date
-
Package Status
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 | 387 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |