Duns Number:076907973
Device Description: Made to add 4" to the width of your OR Table for wider patients or for certain procedures Made to add 4" to the width of your OR Table for wider patients or for certain procedures that may need a wider table. Quickly attaches to the OR Table side rail of any US made O.R. Table. Has a rail on the outer side for accessories so you don't loose any capability in the function of your O.R. Table. .
Catalog Number
MCM405
Brand Name
NA
Version/Model Number
MCM405
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
FWZ
Product Code Name
Operating Room Accessories Table Tray
Public Device Record Key
6bb152fb-6f2e-45c6-a7a2-62b9292594b4
Public Version Date
September 09, 2020
Public Version Number
1
DI Record Publish Date
September 01, 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 |