Margin Probe Console 1.2R

GUDID 07290012534058

The MARGINPROBE System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (less than 1mm) of the main ex-vivo lumpectomy specimen following primary excision and is indicated for intraoperative use, in conjunction with standard methods (such as intraoperative imaging and palpation) in patients undergoing breast lumpectomy surgery for previously diagnosed breast cancer.

DILON MEDICAL TECHNOLOGIES LTD

Intraoperative tumour margin analysis probe

• Primary Device ID: 07290012534058
• NIH Device Record Key: 87ced7df-251c-4e99-b7f3-002543e6ba6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Margin Probe Console 1.2R
• Version Model Number: SA0590020
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	07290012534058 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-28
• Device Publish Date: 2023-03-20

Devices Manufactured by DILON MEDICAL TECHNOLOGIES LTD

• 07290012534058 - Margin Probe Console 1.2R: 2023-03-28The MARGINPROBE System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (less than 1mm) of the main ex-vivo lumpectomy specimen following primary excision and is indicated for intraoperative use, in conjunction with standard methods (such as intraoperative imaging and palpation) in patients undergoing breast lumpectomy surgery for previously diagnosed breast cancer.
• 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: 2021-10-29 The probe is a detachable, sterile, single-use, single-patient component with a 3-year shelf life. It is connected to the consol