AccessGUDID - DEVICE: Footswitch (Straub Medical®) (07640142810919)

GUDID

Device Identifier (DI) Information

Brand Name: Footswitch (Straub Medical®)
Version or Model: Version 1.0
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 80303
Company Name: Straub Medical AG

Primary DI Number: 07640142810919
Issuing Agency: GS1
Commercial Distribution End Date: January 28, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 488489766 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58214	Mechanical atherectomy/thrombectomy drive system	A multi-purpose assembly of devices designed to power and control the mechanical mechanism of an atherectomy and/or thrombectomy catheter (not included) during an intravascular recanalization procedure. It typically consists of an electrically-powered control unit that supplies the drive motor with electricity to power the catheter and a handpiece with hand-switch that includes the drive motor (for catheter manipulation); a foot-switch may also be included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCW	Catheter, Peripheral, Atherectomy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4472f21c-8a47-4f81-95de-0ccdceba7c7c
Public Version Date: January 29, 2025
Public Version Number: 6
DI Record Publish Date: January 31, 2020