Duns Number:245449095
Catalog Number
-
Brand Name
Savaria
Version/Model Number
Stairfriend
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
K023852
Product Code
ILK
Product Code Name
Transport, Patient, Powered
Public Device Record Key
5018107b-7c53-41a0-b8fc-e15850f98fe1
Public Version Date
November 23, 2021
Public Version Number
5
DI Record Publish Date
September 08, 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 | 59 |
2 | A medical device with a moderate to high risk that requires special controls. | 12 |