Duns Number:073814568
Device Description: Disposable Head and Chin Strap to be used with shoulder chairs from a variety of vendors. Disposable Head and Chin Strap to be used with shoulder chairs from a variety of vendors. These are deisgned to reduce the risk of head movement during shoulder surgery when restrained in a surgical beach chair. The straps are a soft handed loop material that will mate with a hook material on the head restraint. A pocket is designed to craddle the chin,. Each kit has 2 straps, 1 for the forehead, and 1 for the chin. they are 22" long and 2" Wide.
Catalog Number
BD050-HCS
Brand Name
NA
Version/Model Number
BD050-HCS
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
FMP
Product Code Name
Protector, Skin Pressure
Public Device Record Key
97d7ecf1-8be3-44e1-880f-85668df73a35
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 |