Duns Number:252287586
Device Description: OPAL/StaageElevator,wheelchair,portable
Catalog Number
-
Brand Name
Vertical Lifts
Version/Model Number
02
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
-
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
K033469
Product Code
ING
Product Code Name
Elevator, Wheelchair, Portable
Public Device Record Key
3b3ba5c0-8e2b-4a34-85d0-dd75eb64b038
Public Version Date
July 06, 2018
Public Version Number
3
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. | 8 |