Duns Number:144008062
Device Description: Rave-II Folding Rail Right Hand
Catalog Number
Rave-II-FR-RH
Brand Name
Rave
Version/Model Number
Rave-II
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
PCD
Product Code Name
Powered stairway chair lift
Public Device Record Key
9630becb-1885-4a1a-8c54-ef12739dba40
Public Version Date
November 18, 2020
Public Version Number
1
DI Record Publish Date
November 10, 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. | 544 |