AccessGUDID - DEVICE: Vari-Lase® Platinum Bright Tip laser fiber (M20671520)

GUDID

Device Identifier (DI) Information

Brand Name: Vari-Lase® Platinum Bright Tip laser fiber
Version or Model: 7152
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Vascular Solutions, Inc.

Primary DI Number: M20671520
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008999906 *Terms of Use

Device Description: The VARI-LASE Platinum Bright Tip laser fiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein and for the treatment of incompetence and reflux of superficial veins in the lower extremity.

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?
47535	Varicose vein lasing procedure kit	A collection of sterile devices and materials designed to perform percutaneous laser treatment of varicose veins and varicosities associated with reflux in the superficial veins of the leg. It typically contains an entry needle, a laser fibre, an introducer sheath, a catheter, a guidewire, a dilator, and connectors to facilitate connection to a laser (e.g., a diode laser) and provide a pathway for the laser energy into the section(s) of the vein to be treated. This device does not contain pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

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: 250 Centimeter
Device Size Text, specify: Unmarked

Device Record Status

Public Device Record Key: 43da1e96-5201-4064-9876-6fe19a74cd1b
Public Version Date: November 11, 2019
Public Version Number: 4
DI Record Publish Date: September 05, 2016