Numen

Basic Information

• Brand Name: Numen
• Primary DI: 06958698010099
• Version / Model: 3D0724FR
• Company Name: MicroPort NeuroTech (Shanghai) Co., Ltd.
• Labeler DUNS: 551973856
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-15
• Public Version: 1
• Public Version Date: 2022-03-23
• Public Version Status: New
• Public Device Record Key: 5ef06511-c6de-4993-8fe0-6c98203890d6

Device Description

The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen Coil Embolization System is composed of two parts as described below: *An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter. *The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HCG	Device, Neurovascular Embolization	Neurology	882.5950	2
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	870.3300	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	06958698010099	GS1

Premarket Submissions

Submission Number	Supplement Number
K203625	000