Synxess

Basic Information

• Brand Name: Synxess
• Primary DI: 06945258302022
• Version / Model: GW1410
• Company Name: Enlight Medical Technologies(Shenzhen) Co., Ltd.
• Labeler DUNS: 545380342
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-08
• Public Version: 1
• Public Version Date: 2025-02-17
• Public Version Status: New
• Public Device Record Key: 24c38b7c-e6f3-407d-855b-960dac5c2f33

Device Description

This product is comprised of a stainless steel core wire with distal platinum tungsten coil and proximal stainless steel coil, and includes a shaping mandrel and a torque device. The guidewire distal tip is straight and shapeable. The diameters of the guidewires are listed in the table below. The guidewires are compatible with devices with inner diameters (IDs) specified in the table below. The distal 30 mm of the guidewire tip is radiopaque. Confirm the compatibility of the guidewire diameter with the interventional device before use. For lubricity, the distal 300 mm of the device is coated with hydrophilic coating and the proximal portion of the guidewire is coated with hydrophobic polytetrafluoroethylene (PTFE).The shaping mandrel included with the guidewire can be used to shape the tip of the guidewire as appropriate. When shaping the tip, carefully crimp it while the surface is wet. The torque device included with the guidewire attaches to the proximal end of the wire and functions as a steering guide. Rotation of the torque device facilitates guidewire placement into the target vessel by manipulation of the guidewire tip.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	870.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60940	Neurovascular embolization coil	A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06945258302022	GS1

Premarket Submissions

Submission Number	Supplement Number
K240871	000