PercuNav Tabletop Field Generator

GUDID 00884838080720

Philips Ultrasound, Inc.

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• Primary Device ID: 00884838080720
• NIH Device Record Key: 73b3c9ad-fc84-41c0-a3c8-c2e66ea4d516
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PercuNav Tabletop Field Generator
• Version Model Number: 989605420101
• Company DUNS: 063377717
• Company Name: Philips Ultrasound, Inc.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838080720 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170716

FDA Product Code

• IYO: System, imaging, pulsed echo, ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-02
• Device Publish Date: 2019-04-24

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