Duns Number:317931954
Device Description: Padding Set for PeroSupport.tec, 3 x padding and 1 x strap with magnetic closure, 10 x hoo Padding Set for PeroSupport.tec, 3 x padding and 1 x strap with magnetic closure, 10 x hook and loop dots, size XS - XL, left and right
Catalog Number
197R10
Brand Name
Padding Set for PeroSupport.tec
Version/Model Number
197R10
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
2b6a04fa-988b-4f76-9661-83acf5030b48
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 |