Duns Number:837845234
Device Description: External remote controller - for use with the FREEDOM residual limb lengthening system
Catalog Number
EAD-P1-020
Brand Name
External Remote Controller
Version/Model Number
P003
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HSB
Product Code Name
Rod, Fixation, Intramedullary And Accessories
Public Device Record Key
3b217011-f8d8-436c-b609-c99fb9a93754
Public Version Date
September 09, 2020
Public Version Number
5
DI Record Publish Date
October 15, 2015
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2199 |