Duns Number:947090650
Device Description: Radiolucent carbon fiber construction Armboard designed to integrate with surgical table s Radiolucent carbon fiber construction Armboard designed to integrate with surgical table side rail and support the patient arm for surgical procedures.
Catalog Number
OZ 7547675
Brand Name
Kit, Berchtold Anesthesia Armboard
Version/Model Number
3-2002-001
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
BWN
Product Code Name
Table And Attachments, Operating-Room
Public Device Record Key
49dcb9e2-45e3-43bf-9824-93ee7baaa8ef
Public Version Date
June 22, 2021
Public Version Number
1
DI Record Publish Date
June 14, 2021
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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |