Solitaire 2

Basic Information

• Brand Name: Solitaire 2
• Primary DI: 00847536003323
• Version / Model: SFR2-4-40
• Catalog Number: SFR2-4-40
• Company Name: Micro Therapeutics, Inc.
• Labeler DUNS: 826110710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-12
• Public Version: 3
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 827caf81-b2de-4707-9d50-3ad57726c940

Device Description

Revascularization Device

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
NRY	CATHETER, THROMBUS RETRIEVER	Cardiovascular	870.1250	2

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	00847536003323	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	4	Millimeter
Length	50	Millimeter
Device Size Text, specify			Usable Length,40,Millimeter;Push Wire Length,180,Centimeter;

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT