40001 PercuNav Coaxial Needle Tracker, 13G x 11 cm

GUDID 00884838082960

Philips Ultrasound, Inc.

Multi-purpose stereotactic surgery system

• Primary Device ID: 00884838082960
• NIH Device Record Key: cfa18e1c-d10e-4ec4-8004-bc74fcfad8f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 40001 PercuNav Coaxial Needle Tracker, 13G x 11 cm
• Version Model Number: 989605427984
• Company DUNS: 063377717
• Company Name: Philips Ultrasound, Inc.
• Device Count: 2
• DM Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838082960 [Primary]
GS1	00884838083066 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132087

FDA Product Code

• JAK: System, x-ray, tomography, computed

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00884838082960]

Ethylene Oxide

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[00884838082960]

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[00884838082960]

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[00884838082960]

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[00884838082960]

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[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

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[00884838082960]

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[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

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[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

[00884838082960]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-25

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