Duns Number:073814568
Device Description: Malleable Anesthesia Screen designed to be a flexible metal frame tiat is moldable and can Malleable Anesthesia Screen designed to be a flexible metal frame tiat is moldable and can keep tubes & drapes from entering the sterile field. Attaches to most operating tables. This anesthesia screen attaches via a clark socket style rail clamp.
Catalog Number
BD200-NC
Brand Name
NA
Version/Model Number
BD200-NC
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
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
785fb83d-f3c9-4bd5-ad33-883efc32646b
Public Version Date
July 15, 2022
Public Version Number
1
DI Record Publish Date
July 07, 2022
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 | 264 |