Duns Number:001307735
Device Description: Corning® 150mm by 25mm Style, Not Tissue Culture-Treated Culture Dish, Bulk Packaged, 5/Ba Corning® 150mm by 25mm Style, Not Tissue Culture-Treated Culture Dish, Bulk Packaged, 5/Bag, 60/Case
Catalog Number
430597
Brand Name
Corning
Version/Model Number
430597
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
KIZ
Product Code Name
DISH, TISSUE CULTURE
Public Device Record Key
0fde3b44-215d-4a3b-9615-43701424da6b
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
October 08, 2020
Package DI Number
H1084305973
Quantity per Package
12
Contains DI Package
H1084305971
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |