Duns Number:867673159
Device Description: Canes & CrutchesOffset Product Description: Cane, Offset,Stars,1EA,6/CS
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
RTL10303SB
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 01, 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
IPS
Product Code Name
CANE
Public Device Record Key
f1668b78-b54c-4ad1-bf64-02ec8acc74aa
Public Version Date
July 17, 2019
Public Version Number
4
DI Record Publish Date
May 19, 2017
Package DI Number
50822383547300
Quantity per Package
6
Contains DI Package
00822383547305
Package Discontinue Date
March 01, 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 |