Hydrophilic Guidewire

GUDID 00802526415913

Lake Region Medical

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• Primary Device ID: 00802526415913
• NIH Device Record Key: e24a3e5d-cdac-4f74-9223-11cc6dee9f24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hydrophilic Guidewire
• Version Model Number: 666411-011
• Company DUNS: 031108704
• Company Name: Lake Region Medical
• 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

Device Dimensions

• Length: 180 Centimeter
• Length: 180 Centimeter
• Length: 180 Centimeter
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 180 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00802526415913 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000011

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-31

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• 8714729839866 - NaviPro™: 2023-12-06
• 08714729839897 - NaviPro™: 2023-12-06
• 08714729839880 - NaviPro™: 2023-12-06
• 08714729839910 - NaviPro™: 2023-12-06
• 08714729839903 - NaviPro™: 2023-12-06
• 08714729839934 - NaviPro™: 2023-12-06
• 08714729839927 - NaviPro™: 2023-12-06