Duns Number:144008062
Device Description: SUMMIT MAX STAIRLIFT
Catalog Number
SL500AC
Brand Name
SUMMIT
Version/Model Number
SL500
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 28, 2017
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
84f2b809-a291-47ea-8465-88dc6fc2d11e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 28, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 544 |