MarginProbe® Probe

Primary DI
07290012534041
Brand
MarginProbe® Probe
Company
DILON MEDICAL TECHNOLOGIES LTD
Model
AC0600001
Device description
The probe is a detachable, sterile, single-use, single-patient component with a 2-year shelf life. It is connected to the console by two RF cables and a vacuum tube, via a single connector.
Published
2025-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OEEDiagnostic Low Electric Field

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEEDiagnostic Low Electric FieldUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P110014013

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P110014013DUNE MEDICAL DEVICES MARGINPROBE SYSTEMDilon Medical Technologies, Ltd.2012-12-27OEE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290012534041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290012534041072900125340417290012534041

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative tumour margin analysis probeA sterile electronic probe intended to be connected to a system analyser (not included) for tissue surface analysis and characterization using radio-frequency spectroscopy, to identify cancerous tissue at the cut-lines (margins) during a lumpectomy procedure. It includes a handpiece with a tissue contact tip and a cable which may include a suction line to allow complete tip/tissue contact. It is intended for systematic analysis of the tissue sample, whereby surfaces identified by the analyser as cancerous correspond to margins which may require further excision. This is a single-use device.

Regulatory Flags#

DUNS number
600832361
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290012534065Margin Probe Console 2.0SA05900402025-10-15
07290012534058Margin Probe Console 1.2RSA05900202023-03-20
07290012534034MarginProbe® ProbeAC03000012021-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290012534065Margin Probe Console 2.0DILON MEDICAL TECHNOLOGIES LTDOEE2025-10-15
07290012534058Margin Probe Console 1.2RDILON MEDICAL TECHNOLOGIES LTDOEE2023-03-20
07290012534034MarginProbe® ProbeDILON MEDICAL TECHNOLOGIES LTDOEE2021-10-21
07290012534010MarginProbe® ProbeDUNE MEDICAL DEVICES LTDOEE2014-10-02