Nexus

Basic Information

• Brand Name: Nexus
• Primary DI: 00836462019485
• Version / Model: X-2-4-T10-HSS
• Catalog Number: X-2-4-T10-HSS
• Company Name: Micro Therapeutics, Inc.
• Labeler DUNS: 826110710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-16
• Public Version: 4
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 4cde3733-eed2-4902-8a31-60478721af4f

Device Description

Detachable Coil

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: Labeling does not contain MRI Safety Information
• 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

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	00836462019485	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K051425	000

Device Sizes

Type	Value	Unit	Text
Length	4	Centimeter
Outer Diameter	2	Millimeter
Device Size Text, specify			Softness Grade,Supersoft,NA;Coil Diameter,0.0095,Inches;