AccessGUDID - DEVICE: VWING Vascular Needle Guide (08199260101465)

GUDID

Device Identifier (DI) Information

Brand Name: VWING Vascular Needle Guide
Version or Model: 00146
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00146
Company Name: VITAL ACCESS CORPORATION

Primary DI Number: 08199260101465
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 180346285 *Terms of Use

Device Description: VWING Vascular Needle Guide 10mm x 7mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
58816	Arteriovenous fistula buttonhole cannulation guide	A metal implant intended to be attached (sutured) to, or placed above, an arteriovenous fistula (AVF) under the skin to act as a guide when using a constant site (buttonhole) method of blunt needle insertion. It is typically used during haemodialysis procedures where the device can be palpated (felt) beneath the skin and the cannulation directed into the device where it will funnel the needle point towards a constant entry site in the vessel wall. It is typically made of titanium (Ti) and is available in a range of sizes.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PFH	Venous Window Needle Guide

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
Special Storage Condition, Specify: Keep dry. Keep away from heat. Store in a dry place at room temperature.

Clinically Relevant Size

[?]

Size Type Text
Height: 10 Millimeter
Width: 7 Millimeter
Length: 18 Millimeter

Device Record Status

Public Device Record Key: 41a2a852-a774-4f8b-bb49-8b1bbfef6bed
Public Version Date: June 17, 2022
Public Version Number: 4
DI Record Publish Date: February 04, 2015