10001 PercuNav Patient Tracker

GUDID 00884838068643

Philips Ultrasound, Inc.

Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system

• Primary Device ID: 00884838068643
• NIH Device Record Key: 2db6b24f-69cc-42a3-b8f6-1a99f13a1f09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 10001 PercuNav Patient Tracker
• Version Model Number: 989605427133
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838068643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132087

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-08
• Device Publish Date: 2016-08-25

Devices Manufactured by Philips Ultrasound, Inc.

• 00884838114203 - EPIQ 7 Diagnostic Ultrasound System Circular Edition: 2024-04-18 10.0.X Circular Edition
• 00884838114210 - EPIQ 5 Diagnostic Ultrasound System Circular Edition: 2024-04-18 10.0.X Circular Edition
• 00884838114227 - EPIQ CVx Diagnostic Ultrasound System Circular Edition: 2024-04-18 10.0.X Circular Edition
• 00884838114234 - EPIQ Elite Diagnostic Ultrasound System Circular Edition: 2024-04-18 10.0.X Circular Edition
• 00884838102729 - Transducer X11-4t: 2024-04-11
• 00884838115323 - QLAB Advanced Quantification Software: 2024-04-11
• 00884838122116 - Lumify Diagnostic Ultrasound System: 2024-04-08 Android 5.0
• 00884838120266 - Lumify Diagnostic Ultrasound System iOS: 2023-08-08 Release 5.0 iOS