AccessGUDID - DEVICE: R350™ guidewire (M20673900)

GUDID

Device Identifier (DI) Information

Brand Name: R350™ guidewire
Version or Model: 7390
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Vascular Solutions, Inc.

Primary DI Number: M20673900
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008999906 *Terms of Use

Device Description: The R350 guidewire is indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
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?
35094	Cardiac/peripheral vascular guidewire, single-use	A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQX	Wire, Guide, Catheter

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: Yes
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
Outer Diameter: 0.013 Inch
Length: 350 Centimeter

Device Record Status

Public Device Record Key: 9e4dbc4f-62f6-4767-8148-078cc6d44bb3
Public Version Date: November 11, 2019
Public Version Number: 4
DI Record Publish Date: September 05, 2016