Duns Number:259777209
Device Description: DROP SEAT - CLASSIC RAIL (F-SERIES)
Catalog Number
-
Brand Name
MODULAR POWER POSITIONING SYSTEM
Version/Model Number
RS-5ES-RESR-CLSC
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 05, 2021
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
K150574
Product Code
ITI
Product Code Name
Wheelchair, Powered
Public Device Record Key
cc822f6e-4591-4de1-b3af-3977ab57e6ba
Public Version Date
August 09, 2021
Public Version Number
4
DI Record Publish Date
September 20, 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. | 176 |