Duns Number:073814568
Device Description: Repalcement 4in. Foam pad for the 10 inch wide table width extender. This ia bariatric tab Repalcement 4in. Foam pad for the 10 inch wide table width extender. This ia bariatric table width extender that attached to the side rail of an OR table. TWE-10
Catalog Number
DSC-TWE10-4in.PAD
Brand Name
NA
Version/Model Number
DSC-TWE10-4in.PAD
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
LWG
Product Code Name
Surgical Table Cushion
Public Device Record Key
a02bc1da-ec71-4428-9bc8-50b2dc85c835
Public Version Date
July 26, 2022
Public Version Number
1
DI Record Publish Date
July 18, 2022
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 | 264 |