AccessGUDID - DEVICE: ONE Snare® (00884450094990)

GUDID

Device Identifier (DI) Information

Brand Name: ONE Snare®
Version or Model: 00884450094990
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ONE701
Company Name: Merit Medical Systems, Inc.

Primary DI Number: 00884450094990
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184763290 *Terms of Use

Device Description: No description.

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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: Catheter Length (cm)-175 cm
Device Size Text, specify: Catheter French Size (F)-2.3 - 3F
Device Size Text, specify: Catheter French Size (F)-2.3 - 3F; Catheter Length (cm)-175 cm; Catheter French Size (F)-2.3 - 3F

Device Record Status

Public Device Record Key: a7d06a7d-93ea-4e09-9ee0-165fe350ab9c
Public Version Date: April 25, 2025
Public Version Number: 4
DI Record Publish Date: September 24, 2016