Duns Number:867673159
Device Description: Part Transport chairs/Wheelchairs Parts Product Description Footrest Rlse.Knob,L3 Coug.1/ Part Transport chairs/Wheelchairs Parts Product Description Footrest Rlse.Knob,L3 Coug.1/e
Catalog Number
-
Brand Name
Drive
Version/Model Number
STDS2A4322
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IMM
Product Code Name
FOOTREST, WHEELCHAIR
Public Device Record Key
77c926a8-a3da-4410-8bd8-291b599f2c29
Public Version Date
February 19, 2020
Public Version Number
1
DI Record Publish Date
February 11, 2020
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 |