Duns Number:008503294
Device Description: ROLL GUARD W/VINYL COVER
Catalog Number
5700SC
Brand Name
POSEY
Version/Model Number
5700SC
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
FNL
Product Code Name
Bed, Ac-Powered Adjustable Hospital
Public Device Record Key
9820e231-d4ad-440d-bae6-afad744da8c9
Public Version Date
October 19, 2022
Public Version Number
4
DI Record Publish Date
September 13, 2016
Package DI Number
20190676000580
Quantity per Package
4
Contains DI Package
10190676000583
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 177 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |