Duns Number:867673159
Device Description: Rollators4-Wheel Alum Product Description: Hugo Elite Roll KD, Blue, 1EA, 2CV, Ret
Catalog Number
-
Brand Name
Hugo
Version/Model Number
700-959
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 21, 2019
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
ITJ
Product Code Name
WALKER, MECHANICAL
Public Device Record Key
d7de7a90-5b49-4d0e-ba72-d8372106639b
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
June 21, 2019
Package DI Number
50754021210881
Quantity per Package
2
Contains DI Package
00754021210886
Package Discontinue Date
June 21, 2019
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |