Duns Number:076907973
Device Description: Standard Drop-Latch Armboard. This armboard is designed to support patient’s arms during s Standard Drop-Latch Armboard. This armboard is designed to support patient’s arms during surgery. Standard droplatch style armboard for ease of use. Rotates 180 degrees to desired position with lever lock. Simply pull lever on underside at the outer end to adjust the rotation of the armboard. Clamps to any American made OR table rail with drop style lock. Simply lift the lever, fit the top of the clamp over the top of the table rail and release the lever to lock in place. .
Catalog Number
MCM410
Brand Name
NA
Version/Model Number
MCM410
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
NOD
Product Code Name
Board, Arm (With Cover), Non-Sterile
Public Device Record Key
64a31314-ac35-49b3-9769-9ef04b92cbdb
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 30, 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 |