AltaTrack Guidewire ATG35120A

GUDID 00884838070974

The AltaTrack Guidewire is a single-use, sterile, hydrophilic guidewire with FORS technology. The primary function of the AltaTrack Guidewire is to direct an AltaTrack Catheter or other compatible catheter to a desired anatomical location. It can be visualized in 3D in real time by the AltaTrack equipment using FORS technology.

Philips Medical Systems Nederland B.V.

Peripheral vascular guidewire, manual

• Primary Device ID: 00884838070974
• NIH Device Record Key: 274056d0-e69c-406c-9a18-2512a3b12ee5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AltaTrack Guidewire
• Version Model Number: 43220701348
• Catalog Number: ATG35120A
• 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: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter
• Lumen/Inner Diameter: 0.035 Inch
• Length: 120 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838070974 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201081

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: 2021-01-29
• Device Publish Date: 2021-01-21

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