Beacon DSA-090-01

GUDID 10884521722583

Beacon EUS Access System

Covidien LP

General-purpose endoscopic needle, single-use

• Primary Device ID: 10884521722583
• NIH Device Record Key: 46fc4018-6a82-4c56-bfd6-88e07105f032
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beacon
• Version Model Number: DSA-090-01
• Catalog Number: DSA-090-01
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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
• 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

• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521722583 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180037

FDA Product Code

• FCG: Biopsy needle
• GAA: Needle, Aspiration And Injection, Disposable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-18
• Device Publish Date: 2019-12-10

On-Brand Devices [Beacon]

• 10855208005176: BNX Fine Needle Fiducial Needle
• 10855208005169: BNX Fine Needle Fiducial Needle
• 00855208005155: BNX Fine Needle Fiducial System
• 00855208005148: BNX Fine Needle Fiducial System
• 10884521722583: Beacon EUS Access System
• 10884521663527: Beacon EUS Access System