Duns Number:967025602
Device Description: 115V Mighty Rest 39-86 Full Electric
Catalog Number
-
Brand Name
Mighty Rest 39-86 Full Electric
Version/Model Number
Xtra39-86
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
FNL
Product Code Name
Bed, Ac-Powered Adjustable Hospital
Public Device Record Key
9b7c59e8-f2be-4d11-ba2e-02f7e7392e4b
Public Version Date
September 03, 2020
Public Version Number
2
DI Record Publish Date
February 06, 2019
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 | 130 |
2 | A medical device with a moderate to high risk that requires special controls. | 139 |