AccessGUDID - DEVICE: Boomerang (00860013182304)

GUDID

Device Identifier (DI) Information

Brand Name: Boomerang
Version or Model: BMGVT080
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Aveera Medical Inc.

Primary DI Number: 00860013182304
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119410497 *Terms of Use

Device Description: The Boomerang Valvulotome is an over-the-wire (OTW) catheter designed to disrupt venous valves in the lower limb. The catheter is positioned percutaneously under fluoroscopic guidance such that the distal tip is advanced across the target venous valve. The catheter has a self-centering basket with shielded cutting blades. As the catheter is retracted, the basket cutting elements disrupt the venous valves, facilitating retrograde vein flow.

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":	Yes
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?
62527	Valvulotome, percutaneous	A sterile, flexible tube with an exposable blade assembly at its distal end designed to incise/excise peripheral venous valves to allow retrograde flow of blood. It is introduced percutaneously over an in-situ guidewire into a vein before being advanced distally to the valves, where the cutting implement is exposed using controls at the proximal end. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MGZ	Valvulotome

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K250105	000

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
Guidewire Diameter: 0.018 Inch
Catheter Gauge: 4 French
Catheter Working Length: 80 Centimeter

Device Record Status

Public Device Record Key: 115ddd0f-1a91-4b8f-b757-ca6b88a360de
Public Version Date: July 22, 2025
Public Version Number: 1
DI Record Publish Date: July 14, 2025