SonoTip® EBUS Pro Flex GUS-42-18-022

GUDID 04052838011440

SonoTip EBUS Pro with Nitinol Needle, Endobronchial Ultrasound Guided TBNA System for Pentax Endoscope, 22 Gauge Needle System, Round Nitinol Stylet,

Medi-Globe GmbH

Body aspiration needle, single-use

• Primary Device ID: 04052838011440
• NIH Device Record Key: 3aada385-ca49-4c99-b841-2274323a8c36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoTip® EBUS Pro Flex
• Version Model Number: GUS-42-18-022
• Catalog Number: GUS-42-18-022
• Company DUNS: 318130267
• Company Name: Medi-Globe GmbH
• 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: true
• 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: +4980329730
• Email: sales@medi-globe.de

Device Dimensions

• Needle Gauge: 22 Gauge

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052838011440 [Package]; Contains: 04052838011457; Package: Box [5 Units]; In Commercial Distribution
GS1	04052838011457 [Primary]

FDA Product Code

• FCG: Biopsy Needle

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-30

On-Brand Devices [SonoTip® EBUS Pro Flex]

• 04052838011488: SonoTip EBUS Pro with Nitinol Needle, Endobronchial Ultrasound Guided TBNA System for Olympus En
• 04052838011440: SonoTip EBUS Pro with Nitinol Needle, Endobronchial Ultrasound Guided TBNA System for Pentax End