Duns Number:655010531
Device Description: Kit for Hyperthermic Perfusion
Catalog Number
R9900120
Brand Name
Hang&Go
Version/Model Number
001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 23, 2020
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
6c2faa08-ecaa-4999-8dca-a72722db9220
Public Version Date
July 24, 2020
Public Version Number
2
DI Record Publish Date
April 27, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 10 |