Navien RFX058-125-08

GUDID 00847536000070

058 Intracranial Support Catheter

Micro Therapeutics, Inc.

Vascular guide-catheter, single-use

• Primary Device ID: 00847536000070
• NIH Device Record Key: 56b9f654-ac1d-4a93-ae42-82f6ea437dca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navien
• Version Model Number: RFX058-125-08
• Catalog Number: RFX058-125-08
• Company DUNS: 826110710
• Company Name: Micro Therapeutics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536000070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110055

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-23
• Device Publish Date: 2015-10-12

On-Brand Devices [Navien]

• 00847536003309: 072 Intracranial Support Catheter
• 00847536003286: 072 Intracranial Support Catheter
• 00847536003262: 072 Intracranial Support Catheter
• 00847536003248: 072 Intracranial Support Catheter
• 00847536003033: 058 Intracranial Support Catheter
• 00847536003019: 072 Intracranial Support Catheter
• 00847536002999: 072 Intracranial Support Catheter
• 00847536002975: 072 Intracranial Support Catheter
• 00847536002951: 072 Intracranial Support Catheter
• 00847536000094: 058 Intracranial Support Catheter
• 00847536000070: 058 Intracranial Support Catheter
• 00847536000056: 058 Intracranial Support Catheter
• 00847536000032: 072 Intracranial Support Catheter
• 00847536000018: 072 Intracranial Support Catheter