Duns Number:867673159
Device Description: Canes & CrutchesCrutches Product Description: Universal Quick Adjust Crutch,1PR,8/CS
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
RTL10433
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
IPR
Product Code Name
CRUTCH
Public Device Record Key
0626359c-a663-4c26-abc5-3ed78a2ad18b
Public Version Date
July 16, 2019
Public Version Number
3
DI Record Publish Date
May 19, 2017
Package DI Number
50822383258961
Quantity per Package
8
Contains DI Package
00822383258966
Package Discontinue Date
-
Package Status
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 |