AccessGUDID - DEVICE: BOSS CSC, Crossing Support Catheter. (05391525640853)

GUDID

Device Identifier (DI) Information

Brand Name: BOSS CSC, Crossing Support Catheter.
Version or Model: 180000090
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MARVAO MEDICAL DEVICES LIMITED

Primary DI Number: 05391525640853
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 896253098 *Terms of Use

Device Description: The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or other diagnostic contrast agents. The device is intended for single use and is provided sterile using Ethylene Oxide gas. The device consists of two low profile catheters, 2.4F and 3.9F, which are compatible with 0.018” and 0.035” guidewires, respectively. The proximal end of each catheter includes a standard catheter hub with Luer fitting and a strain relief. The distal end of both catheters are equipped with a single marker band which enables visibility under fluoroscopy. There is a hydrophilic coating on the distal portion of each catheter shaft to enhance lubricity. The device is provided either as a kit containing one of each size catheter, or as a single pack containing only one catheter. Each catheter is packaged in individual spiral HDPE hoops that are secured to a HDPE card and placed inside a Tyvek Mylar pouch. This model is a 2.4F/90cm length catheter packaged individually

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?
10688	Angiographic catheter, single-use	A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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
No Device Sizes

Device Record Status

Public Device Record Key: 5bbe2019-4e2e-4f52-a0b5-9b86553d4566
Public Version Date: April 24, 2023
Public Version Number: 1
DI Record Publish Date: April 14, 2023