Duns Number:076907973
Device Description: TKR Foot Rest (radiolucent). Assists in supporting legs for total knee replacement procedu TKR Foot Rest (radiolucent). Assists in supporting legs for total knee replacement procedures. Constructed of stainless steel and polyoxy-methylene for ultimate support. Top portion is radiolucent. 5/8" diameter stainless steel post fits into Clark Socket (sold separately). Includes one single use disposable pad of soft black cushion. Replacement pads available for purchase separately..
Catalog Number
MCM612
Brand Name
NA
Version/Model Number
MCM612
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
FWZ
Product Code Name
Operating Room Accessories Table Tray
Public Device Record Key
d4dab461-d222-46ae-bed9-acb74e47a951
Public Version Date
September 09, 2020
Public Version Number
1
DI Record Publish Date
September 01, 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 | 342 |