Duns Number:488489766
Device Description: The footswitch is a pedal that allows the physician to turn the Motor on and off by pressi The footswitch is a pedal that allows the physician to turn the Motor on and off by pressing down the switch, if the physician prefers to operate the system in this way. The footswitch is a part of Straub Medical Drive System.
Catalog Number
80303
Brand Name
Footswitch (Straub Medical®)
Version/Model Number
Version 1.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MCW
Product Code Name
Catheter, Peripheral, Atherectomy
Public Device Record Key
4472f21c-8a47-4f81-95de-0ccdceba7c7c
Public Version Date
June 07, 2022
Public Version Number
4
DI Record Publish Date
January 31, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |