Duns Number:179135769
Device Description: Plus Cryo Console
Catalog Number
5250
Brand Name
Tissue-Tek® TEC™ 6
Version/Model Number
5250
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
-
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
IDW
Product Code Name
DISPENSERS, PARAFFIN
Public Device Record Key
09d1f39e-64ff-4370-b63f-b26665f3ebb2
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
February 06, 2020
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 | 733 |