Orion

Basic Information

• Brand Name: Orion
• Primary DI: 00836462002579
• Version / Model: 105-5098-150
• Company Name: Micro Therapeutics, Inc.
• Labeler DUNS: 826110710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-09
• Public Version: 6
• Public Version Date: 2019-05-17
• Public Version Status: Update
• Public Device Record Key: e9173894-0ef0-4704-91d0-1482766fcd8a

Device Description

105-5098-150 ORION 21 MICRO 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KRA	Catheter, continuous flush	Cardiovascular	870.1210	2

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	00836462002579	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K113289	000

Device Sizes

Type	Value	Unit	Text
Length	150	Centimeter
Device Size Text, specify			Distal OD,2.6,French;Proximal OD,2.4,French;

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT