Galeo EW 406890

GUDID 00814384020093

Extension Guidewire

CONCERT MEDICAL, LLC

Coronary artery guidewire extension

• Primary Device ID: 00814384020093
• NIH Device Record Key: 67d3e854-23d7-4f16-adb8-14ca541beb97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Galeo EW
• Version Model Number: EW
• Catalog Number: 406890
• Company DUNS: 189689800
• Company Name: CONCERT MEDICAL, LLC
• Device Count: 5
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814384020086 [Unit of Use]
GS1	00814384020093 [Primary]

FDA Product Code

• DQX: Wire, Guide, Catheter

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: 2016-09-26

Devices Manufactured by CONCERT MEDICAL, LLC

• 00814384020437 - S-Wire Guidewire System: 2018-07-06 The S-Wire Guidewire System is a sterile, single-use guidewire intended to facilitate the introduction and placement of interven
• 00814384020017 - Galeo: 2018-03-29 Coronary Guidewire
• 00814384020031 - Galeo: 2018-03-29 Coronary Guidewire
• 00814384020055 - Galeo: 2018-03-29 Coronary Guidewire
• 00814384020079 - Galeo: 2018-03-29 Coronary Guidewire
• 00814384020093 - Galeo EW: 2018-03-29Extension Guidewire
• 00814384020093 - Galeo EW: 2018-03-29 Extension Guidewire
• 00814384020116 - Galeo HYDRO: 2018-03-29 Coronary Guidewire
• 00814384020130 - Galeo HYDRO: 2018-03-29 Coronary Guidewire