Duns Number:544392592
Catalog Number
-
Brand Name
Mobility scooter
Version/Model Number
W3431
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
INI
Product Code Name
Vehicle, Motorized 3-Wheeled
Public Device Record Key
e67d486e-2646-4628-be2a-c1f21b31076c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 31, 2016
Package DI Number
06970765970044
Quantity per Package
1
Contains DI Package
06970765970013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |