Duns Number:963886457
Device Description: 5Y0 Vero Care Cliner Recliner No Trendelenburg - Push Back - Fixed Arms
Catalog Number
5Y0
Brand Name
Winco
Version/Model Number
5Y0 Vero
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
INN
Product Code Name
Chair, Adjustable, Mechanical
Public Device Record Key
4475a1de-f6f8-41ac-9483-a67ee6f21c36
Public Version Date
January 07, 2019
Public Version Number
1
DI Record Publish Date
December 07, 2018
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 | 83 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |