Duns Number:036985604
Device Description: The Bariatric Width Extender 4-inch Pads for the Back and Seat Sections X-ray Top (2 Seat The Bariatric Width Extender 4-inch Pads for the Back and Seat Sections X-ray Top (2 Seat 2 Back) and can be used with the 3080 and or 3086 SP General Surgical Table.
Catalog Number
BF557
Brand Name
NA
Version/Model Number
Table Extender
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
BWN
Product Code Name
TABLE AND ATTACHMENTS, OPERATING-ROOM
Public Device Record Key
18f15491-4a05-40bd-8791-ddc604978450
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 |