Duns Number:005036025
Device Description: The Midmark UltraFree Articulating Armboard, Restful Path colored upholstery, is intended The Midmark UltraFree Articulating Armboard, Restful Path colored upholstery, is intended to be used with the 230, 630 and 641 Procedure Chairs, and attaches to either side of the chair and supports the patient's arm during procedures and administering of IVs. The ball joint design permits multi-directional movement. Simply squeeze the lever, position the armboard and release the lever.
Catalog Number
9A81001-868
Brand Name
Midmark
Version/Model Number
9A81001-868
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
GBB
Product Code Name
CHAIR, SURGICAL, AC-POWERED
Public Device Record Key
7ecafd95-e99e-49c0-b8ba-06a48fcc71c0
Public Version Date
May 14, 2020
Public Version Number
1
DI Record Publish Date
May 06, 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 | 838 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 544 |