Duns Number:076907973
Device Description: Surgical Stool with Black Aluminum Base. Surgical stools are a very important feature in a Surgical Stool with Black Aluminum Base. Surgical stools are a very important feature in any OR. This seating has many different colors of 15.75 inch diameter vinyl tops. Rotation lock on seat keeps stable when needed. Designed specifically for the OR with waterfall seams for easy cleaning and foot control height adjustment. Adjusts from 19.5 inches – 26.5 inches. Weight capacity 300 lbs..
Catalog Number
MCM850
Brand Name
NA
Version/Model Number
MCM850
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
FZM
Product Code Name
Stool, Operating-Room
Public Device Record Key
90e7ca46-5779-458d-a8d1-488589f9aa8d
Public Version Date
December 23, 2020
Public Version Number
1
DI Record Publish Date
December 15, 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 |