Brilliant (UDI ACS041121-II)
Manufactured by Lepu Medical Technology (Beijing) Co.,Ltd.
Device Regulatory Overview
The Brilliant (Model/Catalog Number: ACS041121-II) is a medical device manufactured by Lepu Medical Technology (Beijing) Co.,Ltd.. This product is indexed under FDA Product Code / Category Classification DYB within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ACS041121-II
- Product Code / EMDN
- DYB
- Device Name
- 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 sheathintroducer, 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.
- Database Sync Date
- 2026-08-09 09:04:49
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Brilliant?
The registered manufacturer of record for Brilliant is Lepu Medical Technology (Beijing) Co.,Ltd..
What is the Primary UDI-DI identifier for Brilliant?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ACS041121-II.
What classification code is assigned to this device?
This device is registered under product classification code DYB.
Similar Classification Devices (DYB)
Other Devices by Lepu Medical Technology (Beijing) Co.,Ltd.
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