Duns Number:036985604
Device Description: The Shoulder Chair is used for open or arthroscopic procedures, features a unique, multi a The Shoulder Chair is used for open or arthroscopic procedures, features a unique, multi axis head positioning capability, which allows for easy intubation and head posturing.
Catalog Number
BF594
Brand Name
NA
Version/Model Number
Shoulder Chair
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 14, 2021
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GBB
Product Code Name
CHAIR, SURGICAL, AC-POWERED
Public Device Record Key
4a49ee27-c4e5-4b10-928a-4021f34ba6d0
Public Version Date
June 14, 2021
Public Version Number
3
DI Record Publish Date
April 02, 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 | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |