MNAV FIDUCIAL MARKERS

GUDID 10815212026673

FIDUCIAL MARKERS AND SKIN MARKER PEN

Izi Medical Products, LLC

Radiological image marker, noninvasive, single-use Radiological image marker, noninvasive, single-use Radiological image marker, noninvasive, single-use Radiological image marker, noninvasive, single-use Radiological image marker, noninvasive, single-use Radiological image marker, noninvasive, single-use Radiological image marker, noninvasive, single-use Radiological image marker, noninvasive, single-use Radiological image marker, noninvasive, single-use Radiological image marker, noninvasive, single-use Radiological image marker, noninvasive, single-use Radiological image marker, noninvasive, single-use Radiological image marker, noninvasive, single-use Radiological image marker, noninvasive, single-use Radiological image marker, noninvasive, single-use Radiological image marker, noninvasive, single-use Radiological image marker, noninvasive, single-use

• Primary Device ID: 10815212026673
• NIH Device Record Key: 560ec20c-34c5-4aaa-9dcd-392f1c6ac29b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MNAV FIDUCIAL MARKERS
• Version Model Number: 960-991
• Company DUNS: 933506164
• Company Name: Izi Medical Products, LLC
• 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: true
• 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	00815212020261 [Previous]
GS1	00815212026676 [Primary]
GS1	10815212026673 [Package]; Contains: 00815212026676; Package: Bag [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014022

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2023-11-24
• Device Publish Date: 2023-11-16

Devices Manufactured by Izi Medical Products, LLC

• 00815212026867 - MDT NAVIGATED BIOPSY, COMPATIABLE 7D: 2024-03-26
• 00815212026812 - ONPOINT NAVIGATION KIT: 2024-03-06
• 00815212026829 - ONPOINT NAVIGATION TRAY: 2024-03-06
• 00815212026836 - ONPOINT SNAP SPHERZ 25PK: 2024-03-06
• 00815212026843 - ONPOINT SPHERZ PASSIVE MARKER-12 PACK: 2024-03-06
• 00815212026850 - ONPOINT PEDICLE ACCESS NEEDLE: 2024-03-06
• 10815212026819 - ONPOINT NAVIGATION 10 BOX: 2024-03-06
• 20815212026816 - ONPOINT NAVIGATION 25 BOXES: 2024-03-06