Neuroform Stabilizer

Basic Information

• Brand Name: Neuroform Stabilizer
• Primary DI: 07613252193951
• Version / Model: M003SNF3STA0
• Catalog Number: M003SNF3STA0
• Company Name: Stryker Corporation
• Labeler DUNS: 042405446
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-02
• Public Version: 7
• Public Version Date: 2020-08-27
• Public Version Status: Update
• Public Device Record Key: 8173372f-172b-444d-ac2c-e461848c291b

Device Description

2F Stabilizer Catheter

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
NJE	intracranial neurovascular stent	Unknown		f

GMDN Terms

Code	Name	Definition	Implantable	Status
10691	Vascular microcatheter	A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613252193951	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
H020002	000
H020002	003
H020002	005
H020002	009
H020002	011
H020002	012
H020002	031
H020002	035
H020002	047
H020002	053
H020002	054

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	0.016	Inch
Length	152.0	Centimeter

Storage Conditions

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