Brilliant

GUDID 16936733738044

The puncture needle or an intravascular catheter incorporates a lumen, which provides a conduit for the insertion of the guide wire into the vascular system. The various types of guide wires, model dependent, are utilized as a guiding mechanism for the insertion of the introduction sheath into the vascular system. The guide wire contains a wire collimator, which assists in funneling the wire through the lumen of the puncture needle or the intravascular catheter and contains marking that are visible under fluoroscopy, which can determine the length of the guide wire within the vascular system. The sheath introducer provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vasculature. The main components of the sheath introducer assembly are a hydrophilic coated sheath introducer, hemostasis valve housing, and a side port with tubing connected to a 3-way stopcock/valve. The hydrophilic coated dilator is used to provide support and stability to the sheath introducer during deployment into the vascular system. The proximal end of the dilator includes a luer port and has a tapered, atraumatic distal tip. Both the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.

Lepu Medical Technology (Beijing) Co.,Ltd.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 16936733738044
• NIH Device Record Key: 646dedea-4da9-4149-ae3f-fb80ad0d6636
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brilliant
• Version Model Number: CS070718
• Company DUNS: 529853921
• Company Name: Lepu Medical Technology (Beijing) Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06936733738047 [Primary]
GS1	16936733738044 [Package]; Contains: 06936733738047; Package: Box [5 Units]; In Commercial Distribution

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-11-16

Devices Manufactured by Lepu Medical Technology (Beijing) Co.,Ltd.

• 16936733735883 - Angioway: 2020-05-06 The inflation device is applied to inflate/deflate balloon catheters and monitor pressure within the balloon.
• 16936733735890 - Angioway: 2020-05-06 The inflation device is applied to inflate/deflate balloon catheters and monitor pressure within the balloon.
• 16936733735920 - Angioway: 2020-05-06 Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment (such as percutaneous coronary
• 16936733735937 - Angioway: 2020-05-06 Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment (such as percutaneous coronary
• 16936733735944 - Angioway: 2020-05-06 Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment (such as percutaneous coronary
• 16936733735951 - Angioway: 2020-05-06 Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment (such as percutaneous coronary
• 16936733735968 - Angioway: 2020-05-06 Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment (such as percutaneous coronary
• 16936733735975 - Angioway: 2020-05-06 Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment (such as percutaneous coronary