Duns Number:867673159
Device Description: PowerFolding Power Product Description: Crutch Holder Set, SType, 1/ea
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
SF8050
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
KNN
Product Code Name
COMPONENTS, WHEELCHAIR
Public Device Record Key
eb763de5-eac4-40b0-b909-58a174fae271
Public Version Date
July 16, 2019
Public Version Number
3
DI Record Publish Date
May 19, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |