BOSS CSC, Crossing Support Catheter. 180000090

GUDID 05391525640815

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

MARVAO MEDICAL DEVICES LIMITED

Angiographic catheter, single-use

• Primary Device ID: 05391525640815
• NIH Device Record Key: 7d5e3b7c-2f34-4318-9ac7-ff9b64f6802b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOSS CSC, Crossing Support Catheter.
• Version Model Number: 180000090
• Catalog Number: 180000090
• Company DUNS: 896253098
• Company Name: MARVAO MEDICAL DEVICES LIMITED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +35391759301
• Email: chris.davey@marvaomedical.com
• Phone: +35391759301
• Email: chris.davey@marvaomedical.com
• Phone: +35391759301
• Email: chris.davey@marvaomedical.com
• Phone: +35391759301
• Email: chris.davey@marvaomedical.com
• Phone: +35391759301
• Email: chris.davey@marvaomedical.com
• Phone: +35391759301
• Email: chris.davey@marvaomedical.com
• Phone: +35391759301
• Email: chris.davey@marvaomedical.com
• Phone: +35391759301
• Email: chris.davey@marvaomedical.com
• Phone: +35391759301
• Email: chris.davey@marvaomedical.com
• Phone: +35391759301
• Email: chris.davey@marvaomedical.com
• Phone: +35391759301
• Email: chris.davey@marvaomedical.com
• Phone: +35391759301
• Email: chris.davey@marvaomedical.com
• Phone: +35391759301
• Email: chris.davey@marvaomedical.com
• Phone: +35391759301
• Email: chris.davey@marvaomedical.com
• Phone: +35391759301
• Email: chris.davey@marvaomedical.com
• Phone: +35391759301
• Email: chris.davey@marvaomedical.com
• Phone: +35391759301
• Email: chris.davey@marvaomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391525640815 [Primary]

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-24
• Device Publish Date: 2023-04-14

On-Brand Devices [BOSS CSC, Crossing Support Catheter. ]

• 05391525640952: The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire durin
• 05391525640914: The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire durin
• 05391525640853: The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire durin
• 05391525640815: The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire durin
• 05391525640754: The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire durin
• 05391525640716: The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire durin
• 05391525640655: The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire durin
• 05391525640563: The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire durin
• 05391525640556: The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire durin
• 05391525640525: The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire durin
• 05391525640617: The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire durin