Duns Number:005036025
Device Description: The Midmark UltraFree Hand Surgery Armboard, Branch colored upholstery, is intended to be The Midmark UltraFree Hand Surgery Armboard, Branch 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 on the upper extremities. The adjustable leg extends to the floor for increased stability while the attachment clamp allows for rotary adjustment of the armboard.
Catalog Number
9A82001-864
Brand Name
Midmark
Version/Model Number
9A82001-864
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
4909ce1c-b1bb-4c82-9e68-4104e36f56c8
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 |