DEVICE: MarginProbe® Probe (07290012534010)
Device Identifier (DI) Information
MarginProbe® Probe
AC0300001
In Commercial Distribution
DUNE MEDICAL DEVICES LTD
AC0300001
In Commercial Distribution
DUNE MEDICAL DEVICES LTD
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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Electrical impedance spectrometer | A mains electricity (AC-powered) instrument intended to measure/map the differences in capacitance and resistance between neoplastic and surrounding normal tissue. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement and/or imaging of local distributions of tissue electrical impedance, in a range of frequencies, by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. It is intended to indicate cytological and histological tissue changes typically in combination with other methodologies (e.g., mammography, visual examination). |
FDA Product Code
[?]Product Code | Product Code Name |
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OEE | Diagnostic Low Electric Field |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
1ed39a30-1458-4d83-8c3f-684eef95ba08
March 29, 2018
2
October 02, 2014
March 29, 2018
2
October 02, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined