Duns Number:001307735
Device Description: Amine 384 Well Black Plate, 5/Pack, 50/Case
Catalog Number
356719
Brand Name
Corning® PureCoat™
Version/Model Number
356719
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
KIZ
Product Code Name
DISH, TISSUE CULTURE
Public Device Record Key
68d8a594-a45d-4701-bea9-4b85db9cd062
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
April 26, 2019
Package DI Number
50389151000196
Quantity per Package
10
Contains DI Package
20389151000195
Package Discontinue Date
-
Package Status
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 | 387 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |