Duns Number:076907973
Device Description: Radiolucent Height Adjustable Armboard with Posi-Lock. This armboard is designed to suppor Radiolucent Height Adjustable Armboard with Posi-Lock. This armboard is designed to support patient’s arms during surgery. Large portion of board is also radiolucent for C-arm capabilities. Rotates 180 degrees to desired position. It also adjusts in height to match the top of the OR table or to elevate the patients arm if needed. Adjusts up to 4 in height. Standard size is 6" x 26". Clamps securely to any American made OR table rail. Uses 26" L armboard pad sold separately..
Catalog Number
MCM401
Brand Name
NA
Version/Model Number
MCM401
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
8eaf1c79-b69f-4ae0-99a1-04fe8d5ba383
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 |