Duns Number:317931954
Device Description: PeroSupport.pro, Ankle-Foot-Orthosis with additional calve stabilisation, made of carbon-p PeroSupport.pro, Ankle-Foot-Orthosis with additional calve stabilisation, made of carbon-prepreg, dynamic, left, shoe size 42 - 45
Catalog Number
197R6/L3
Brand Name
PeroSupport.tec
Version/Model Number
197R6/L3
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
OHI
Product Code Name
Orthosis, Foot Drop
Public Device Record Key
84078889-3896-4044-8149-04622301bc84
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
November 02, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 64 |