40005 PercuNav Coaxial Needle Tracker, 18G x 8 cm

GUDID 00884838083011

Philips Ultrasound, Inc.

Multi-purpose stereotactic surgery system

• Primary Device ID: 00884838083011
• NIH Device Record Key: 83e20c03-1946-4cf2-9622-0f527a3c035f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 40005 PercuNav Coaxial Needle Tracker, 18G x 8 cm
• Version Model Number: 989605428024
• 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	00884838083011 [Primary]
GS1	00884838083103 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132087

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

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

[00884838083011]

Ethylene Oxide

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[00884838083011]

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Ethylene Oxide

[00884838083011]

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[00884838083011]

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[00884838083011]

Ethylene Oxide

[00884838083011]

Ethylene Oxide

[00884838083011]

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[00884838083011]

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[00884838083011]

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[00884838083011]

Ethylene Oxide

[00884838083011]

Ethylene Oxide

[00884838083011]

Ethylene Oxide

[00884838083011]

Ethylene Oxide

[00884838083011]

Ethylene Oxide

[00884838083011]

Ethylene Oxide

[00884838083011]

Ethylene Oxide

[00884838083011]

Ethylene Oxide

[00884838083011]

Ethylene Oxide

[00884838083011]

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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