Duns Number:947090650
Device Description: Surgical support table with stabilizing leg and surgeon elbow rests. This device attaches Surgical support table with stabilizing leg and surgeon elbow rests. This device attaches to a surgical tables side rails via an accessory clamp.
Catalog Number
-
Brand Name
Microsurgical Arm and Hand Table with 4 inch Pad
Version/Model Number
1-1016-003
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
BWN
Product Code Name
Table And Attachments, Operating-Room
Public Device Record Key
634a820e-166c-4e5e-aaca-c708bffd40d1
Public Version Date
March 06, 2020
Public Version Number
1
DI Record Publish Date
February 27, 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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |