Duns Number:073814568
Device Description: A Reusable Well Holder for a non operative leg during knee surgery. It is a covered pad th A Reusable Well Holder for a non operative leg during knee surgery. It is a covered pad the that allows the leg to sit in a trough that is bent at almost 90° to secure the leg when bent hanging over the edge of an OR table.
Catalog Number
BB-WLH
Brand Name
NA
Version/Model Number
BB-WLH
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
ca1cd31c-6f54-4757-8053-d19051235e23
Public Version Date
July 15, 2022
Public Version Number
1
DI Record Publish Date
July 07, 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 |