Duns Number:144008062
Device Description: Ameriglide, Platform lift, 10 ft, Standard, commercial, hoistway by others, AC, indoor
Catalog Number
VPL1000ACAACI
Brand Name
Stratos
Version/Model Number
VPL
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
PCE
Product Code Name
Permanently mounted wheelchair platform lift
Public Device Record Key
531dcc89-a2ec-4a7f-95f3-568c8a592798
Public Version Date
December 01, 2020
Public Version Number
1
DI Record Publish Date
November 23, 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 |