Duns Number:146220269
Device Description: Ankle foot orthosis, prefabricated (single) with toe stilt, to be attached to abduction br Ankle foot orthosis, prefabricated (single) with toe stilt, to be attached to abduction brace, L1930 and L3380 eachAFO SIZE 8 TS RIGHT GRAY
Catalog Number
-
Brand Name
MD Orthopaedics
Version/Model Number
AFO-8-RW-TS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 09, 2020
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KNP
Product Code Name
Orthosis, Corrective Shoe
Public Device Record Key
c2c19b3b-f39e-4cac-8e82-b203ade2967e
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
October 05, 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 | 356 |