MarginProbe® Probe

GUDID 07290012534034

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 a vacuum tube, via a single connector.

DILON MEDICAL TECHNOLOGIES LTD

Intraoperative tumour margin analysis probe

• Primary Device ID: 07290012534034
• NIH Device Record Key: d6d0b8ba-7045-4d6f-a0af-888549b6b15f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MarginProbe® Probe
• Version Model Number: AC0300001
• Company DUNS: 600832361
• Company Name: DILON MEDICAL TECHNOLOGIES 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	07290012534034 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-29
• Device Publish Date: 2021-10-21

Devices Manufactured by DILON MEDICAL TECHNOLOGIES LTD

• 07290012534058 - Margin Probe Console 1.2R: 2023-03-28 The MARGINPROBE System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (less than 1mm) of
• 07290012534034 - MarginProbe® Probe: 2021-10-29The 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 a vacuum tube, via a single connector.
• 07290012534034 - MarginProbe® Probe: 2021-10-29 The probe is a detachable, sterile, single-use, single-patient component with a 3-year shelf life. It is connected to the consol