AccessGUDID - DEVICE: Vascular Solutions Custom Access Kit (M20677191)

GUDID

Device Identifier (DI) Information

Brand Name: Vascular Solutions Custom Access Kit
Version or Model: 7719
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Vascular Solutions, Inc.

Primary DI Number: M20677191
Issuing Agency: HIBCC
Commercial Distribution End Date: January 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 008999906 *Terms of Use

Device Description: The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following a needle stick.

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:	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?
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
Needle Gauge: 21 Gauge
Catheter Gauge: 5 French

Device Record Status

Public Device Record Key: 44b95860-9ded-4d6c-a6d8-0c4470f55069
Public Version Date: June 09, 2023
Public Version Number: 5
DI Record Publish Date: September 05, 2016