Duns Number:867673159
Device Description: Canes & CrutchesAccessories Product Description: HUGO CR. PADS, 1PR,6PR/CV,72PR/CT,Ret
Catalog Number
-
Brand Name
Hugo
Version/Model Number
727-180
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
IPR
Product Code Name
CRUTCH
Public Device Record Key
c8ac19c9-0e4f-4954-b0f4-cbfc71fbdf87
Public Version Date
June 02, 2020
Public Version Number
2
DI Record Publish Date
June 21, 2019
Package DI Number
10754021210951
Quantity per Package
72
Contains DI Package
50754021210959
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 |