AccessGUDID - DEVICE: Micro Elite™ snare (M20683010)

GUDID

Device Identifier (DI) Information

Brand Name: Micro Elite™ snare
Version or Model: 8301
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Vascular Solutions, Inc.

Primary DI Number: M20683010
Issuing Agency: HIBCC
Commercial Distribution End Date: November 27, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 008999906 *Terms of Use

Device Description: The MICRO Elite Snare is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.

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
DQY	Catheter, Percutaneous

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
Length: 180 Centimeter
Device Size Text, specify: 4 mm Snare Loop
Outer Diameter: 0.014 Inch

Device Record Status

Public Device Record Key: 2ebff5cb-1500-4dc7-aff0-498f532984d8
Public Version Date: June 09, 2023
Public Version Number: 6
DI Record Publish Date: September 05, 2016