Duns Number:867673159
Device Description: Canes & CrutchesAccessories Product Description: CANETIP 7/8" BLACK, 6EA/CV, 24EA/CT, Ret
Catalog Number
-
Brand Name
Drive
Version/Model Number
735-135
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
INP
Product Code Name
TIPS AND PADS, CANE, CRUTCH AND WALKER
Public Device Record Key
b4f37c43-b583-4942-929e-9419b16adc3f
Public Version Date
June 02, 2020
Public Version Number
2
DI Record Publish Date
June 21, 2019
Package DI Number
10754021215222
Quantity per Package
24
Contains DI Package
50754021215220
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 |