MarginProbe® Probe

GUDID 07290012534010

The probe is a detachable, sterile, single-use, single-patient component with a 3-year shelf life. It is connected to the console by two RF cables and

DUNE MEDICAL DEVICES LTD

Intraoperative tumour margin analysis probe

• Primary Device ID: 07290012534010
• NIH Device Record Key: 1ed39a30-1458-4d83-8c3f-684eef95ba08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MarginProbe® Probe
• Version Model Number: AC0300001
• Company DUNS: 533247359
• Company Name: DUNE MEDICAL DEVICES LTD
• 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: true
• 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	07290012534010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P110014

FDA Product Code

• OEE: Diagnostic Low Electric Field

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-10-02