Duns Number:036985604
Device Description: The Shoulder Beach Chair attaches to the Cmax, STERIS 4085 General, STERIS 5085 SRT and ST The Shoulder Beach Chair attaches to the Cmax, STERIS 4085 General, STERIS 5085 SRT and STERIS 5085 General Surgical Tables seat section. and is used for open or arthroscopic procedures.
Catalog Number
BF590
Brand Name
NA
Version/Model Number
BF590
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)
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
573b5633-979b-422a-9071-34ad036ae371
Public Version Date
May 03, 2021
Public Version Number
1
DI Record Publish Date
April 23, 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 |