Duns Number:076907973
Device Description: Malleable Anesthesia Screen supports drapes for anesthetists during surgical procedures to Malleable Anesthesia Screen supports drapes for anesthetists during surgical procedures to assist in monitoring patients. Mounts to both side rails of the OR Table with the 5/8" diameter mounting post. Can be formed to fit any shape and easily adjusts for equipment and procedure needs. Fits standard clark socket (MCM160 sold separately). Very durable.
Catalog Number
MCM106
Brand Name
NA
Version/Model Number
MCM106
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
4617885b-a557-4a2f-ba98-2539d0da6742
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 |