Galeo HYDRO 406891

GUDID 00814384020116

Coronary Guidewire

CONCERT MEDICAL, LLC

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00814384020116
• NIH Device Record Key: 878c69f8-b3a8-42e6-8f00-5bf5161b0404
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Galeo HYDRO
• Version Model Number: HF
• Catalog Number: 406891
• 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	00814384020109 [Unit of Use]
GS1	00814384020116 [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

On-Brand Devices [Galeo HYDRO]

• 00814384020178: Coronary Guidewire
• 00814384020154: Coronary Guidewire
• 00814384020130: Coronary Guidewire
• 00814384020116: Coronary Guidewire