Duns Number:076907973
Device Description: Stand Alone leg Prep. This is the new stand alone leg prep from Mid Central Medical. There Stand Alone leg Prep. This is the new stand alone leg prep from Mid Central Medical. There are many types of leg preppers in the industry that mount directly to the surgical table rail and support patients lower limbs. However, these all attach to the table and are limited in positioning. The stand alone leg prep can be used next to the table just as most others are used but can also be placed independently away from the table for various types of cases. Another great use for this leg prep is when surgery is performed on a stretcher or gurney instead of an OR Table. There is no rail on the stretcher to accommodate the standard leg prep but the stand alone leg prep is a great fit! Can be used in infinite positions for arms and legs, whatever the procedure. With rotating support, pretty much any position can be achieved.
Catalog Number
MCM154
Brand Name
NA
Version/Model Number
MCM154
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
625dd9cd-44fc-4022-b567-0382b468ca77
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 |