NEUROFORM EZ 3

Basic Information

• Brand Name: NEUROFORM EZ 3
• Primary DI: 04546540697776
• Version / Model: M003N3EZ30300
• Catalog Number: M003N3EZ30300
• Company Name: Stryker Corporation
• Labeler DUNS: 042405446
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-05-29
• Public Version: 8
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 844bb72c-0d8f-427f-bf43-b6e33d7229de

Device Description

Stent System

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
NJE	intracranial neurovascular stent	Unknown		f

GMDN Terms

Code	Name	Definition	Implantable	Status
46352	Bare-metal intracranial vascular stent	A non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)] and self-expands after it is delivered to the site of implantation and released (e.g., from a dedicated delivery instrument). Disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04546540697776	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
H020002	016
H020002	017
H020002	020
H020002	021
H020002	023
H020002	024
H020002	026
H020002	027
H020002	028
H020002	029
H020002	030
H020002	032
H020002	033
H020002	034
H020002	036
H020002	037
H020002	038
H020002	042
H020002	044
H020002	048
H020002	053
H020002	055
H020002	056

Device Sizes

Type	Value	Unit	Text
Length	30.0	Millimeter
Outer Diameter	3.0	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in cool, dry, dark place.