Duns Number:217190495
Device Description: Kryo 360 Controlled Rate Freezer. 3.3 Litre Chamber
Catalog Number
-
Brand Name
Kryo 360 Freezer
Version/Model Number
GDKRYO360-3.3-115
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
-
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
KSP
Product Code Name
Apparatus, Cell-Freezing And Reagents
Public Device Record Key
e527bdc8-e838-44e2-9de2-f7a5a0cca9bf
Public Version Date
October 28, 2019
Public Version Number
3
DI Record Publish Date
September 23, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |