AccessGUDID - DEVICE: Quattro Elite™ snare (M20684110)

GUDID

Device Identifier (DI) Information

Brand Name: Quattro Elite™ snare
Version or Model: 8411
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Vascular Solutions, Inc.

Primary DI Number: M20684110
Issuing Agency: HIBCC
Commercial Distribution End Date: September 30, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 008999906 *Terms of Use

Device Description: The QUATTRO Elite Snares are intended for use in the cardiovascular system and hollow viscus to retrieve and/or manipulate objects using minimally invasive surgical procedures. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the cardiovascular system.

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?
17927	Intravascular extraction catheter-snare	A flexible, end- and/or side-hole tube with a long snaring device (e.g., a wire loop or noose) inserted through its lumen, designed to be introduced into a blood vessel or similar structure to manually retrieve or manipulate a foreign body. It is typically available in two forms: 1) the loop emerges from the distal tip of the catheter while both free ends of the wire emerge from the proximal end; and 2) the end of the wire is attached to the distal end of the catheter while the free end is passed through the lumen to emerge at the proximal end. The wire is usually made of a high-strength, stiff metal [e.g., nickel-titanium alloy (Nitinol)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMX	Device, Percutaneous Retrieval

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
Device Size Text, specify: 10 mm Snare Loop
Length: 150 Centimeter
Outer Diameter: 0.035 Inch

Device Record Status

Public Device Record Key: cf9b2194-5c05-4e95-8fd7-6176f21a0030
Public Version Date: July 08, 2021
Public Version Number: 6
DI Record Publish Date: September 05, 2016