gudid
Primary ID: FS070535
Shoocin (UDI FS070535)
Manufactured by Lepu Medical Technology (Beijing) Co.,Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Shoocin - Primary ID FS070535
Device Regulatory Overview
The Shoocin (Model/Catalog Number: FS070535) 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
- FS070535
- 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 FS070535.
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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