LumiGuide LGN35160A3DP

GUDID 00884838111127

Angiographic guidewire with FORS technology, intended to direct a catheter during navigation in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.

Philips Medical Systems Nederland B.V.

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• Primary Device ID: 00884838111127
• NIH Device Record Key: a010d721-c979-4961-8882-0ddb9bea6492
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LumiGuide
• Version Model Number: LumiGuide Navigation Wire 3D Plus
• Catalog Number: LGN35160A3DP
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• 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

Device Dimensions

• Lumen/Inner Diameter: 0.035 Inch
• Length: 160 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 160 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 160 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 160 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 160 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 160 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 160 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 160 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 160 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 160 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 160 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 160 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838111127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233853

FDA Product Code

• DQX: Wire, Guide, Catheter

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: 2024-04-01
• Device Publish Date: 2024-03-22

On-Brand Devices [LumiGuide]

• 00884838112087: Visualization device with FORS technology intended to aid the positioning and navigation of a co
• 10884838111148: The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used i
• 00884838111127: Angiographic guidewire with FORS technology, intended to direct a catheter during navigation in
• 00884838111110: Angiographic guidewire with FORS technology, intended to direct a catheter during navigation in