Duns Number:036985604
Device Description: The Bariatric Table Extenders without Pads: Leg Section are radiolucent modular Extenders The Bariatric Table Extenders without Pads: Leg Section are radiolucent modular Extenders that increases the width of the Cmax, 4085, 5085 and or 5085SRT Surgical Tables by 28-inches. The set includes two Extenders each for the Leg Section.
Catalog Number
BF664
Brand Name
NA
Version/Model Number
X-Ray Table Top
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
FQO
Product Code Name
TABLE, OPERATING-ROOM, AC-POWERED
Public Device Record Key
238b393c-2181-4133-ac2a-36365579fd56
Public Version Date
April 12, 2021
Public Version Number
1
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 |