Shoocin (UDI RS070718S-II)
Manufactured by Lepu Medical Technology (Beijing) Co.,Ltd.
Device Regulatory Overview
The Shoocin (Model/Catalog Number: RS070718S-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
- RS070718S-II
- Product Code / EMDN
- DYB
- Device Name
- The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire collimator, a sheath introducer, and a dilator. The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guide Wire into the vascular system. The flexible stainless-steel guide wire is utilized as a guiding mechanism for the insertion of the Introducer 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. The Guide Wire is radio-detective under fluoroscopy. The Sheath Introducer contains Barium sulfate (BaSO4), making the device visible under fluoroscopyand provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vascular system. The main components of this assembly are a non-hydrophilic coated Sheath Introducer, hemostasis valve housing, and a side port tubing with a 3-way stopcock/valve. The 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. There is no radiocontrast agent on the dilator.
- Database Sync Date
- 2026-08-09 09:04:49
Full Regulatory Attributes
🔒 Token Gated
{
"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 Shoocin?
The registered manufacturer of record for Shoocin is Lepu Medical Technology (Beijing) Co.,Ltd..
What is the Primary UDI-DI identifier for Shoocin?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is RS070718S-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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