Neuroform3

Basic Information

• Brand Name: Neuroform3
• Primary DI: 07613252193845
• Version / Model: M003SNF335100
• Catalog Number: M003SNF335100
• 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: 7
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 3624e69b-cf52-4fe2-90b5-75e037c4da48

Device Description

Microdelivery 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	07613252193845	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
H020002	001
H020002	002
H020002	004
H020002	005
H020002	006
H020002	007
H020002	008
H020002	011
H020002	012
H020002	013
H020002	014
H020002	015
H020002	017
H020002	020
H020002	021
H020002	022
H020002	025
H020002	027
H020002	029
H020002	030
H020002	032
H020002	033
H020002	034
H020002	036
H020002	039
H020002	040
H020002	041
H020002	042
H020002	043
H020002	045
H020002	047
H020002	049
H020002	050
H020002	053
H020002	054
H020002	055

Device Sizes

Type	Value	Unit	Text
Length	10.0	Millimeter
Outer Diameter	3.5	Millimeter

Storage Conditions

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