Duns Number:073814568
Device Description: A contoured foam flexing arm cradle that fits on a traditional O.R. Arm board. This allow A contoured foam flexing arm cradle that fits on a traditional O.R. Arm board. This allows for bent arm support in the prone position.This is a reusable product ot replace similar disposable versions. The covering is similar to your traditional O.R. table pads or foam arm board pads.
Catalog Number
1700-SG
Brand Name
NA
Version/Model Number
1700-SG
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
2b24e789-3739-4dd8-8b66-c0ca652645a1
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 |