Duns Number:736558755
Device Description: FloorBed / Empresa Standard Bed Lever Assist Bar, FB6
Catalog Number
STLEV-0-FL6-000
Brand Name
Accora FloorBed 6 Bed Lever Assist Bar
Version/Model Number
Bed Lever Assist Bar
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
IKX
Product Code Name
Aid, Transfer
Public Device Record Key
ce64cd2e-8396-4f1e-83bd-f9f705c612b9
Public Version Date
July 21, 2021
Public Version Number
2
DI Record Publish Date
February 01, 2021
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 | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 3 |