Duns Number:001307735
Device Description: Cellstack, 10 Layer, TCT, Snap cap accessories with Filter and ASG connector 1 per bag, 4 Cellstack, 10 Layer, TCT, Snap cap accessories with Filter and ASG connector 1 per bag, 4 per case
Catalog Number
7608
Brand Name
Corning
Version/Model Number
7608
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
34e345a3-04cd-4ae9-a9b7-bfdc65d52418
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
January 25, 2022
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 |
---|---|---|
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 |