Duns Number:076907973
Device Description: Anesthesia Protection Shield. This stainless steel anesthesia shield is designed to protec Anesthesia Protection Shield. This stainless steel anesthesia shield is designed to protect the patient’s face during surgery and also provides a frame for the anesthesia drape. Constructed of durable stainless steel, it attaches to the OR table rail with two stainless steel side rail sockets (MCM-162 sold separately). Top surface measures 18 1/4" by 22 1/4" and the side supports are 24"L to adjust to the desired height. Side supports measure 1/8" x 1". The flat tray portion can be used to support instruments during surgery. Allows full patient access for anesthesia monitoring. Fully welded stainless steel construction makes it easy to clean and durable.
Catalog Number
MCM107
Brand Name
NA
Version/Model Number
MCM107
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
16dd784e-2d93-4ef7-9e6b-421924a9520e
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 |