DEVICE: MarginProbe® Probe (07290012534010)

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Device Identifier (DI) Information

MarginProbe® Probe
AC0300001

DUNE MEDICAL DEVICES LTD
07290012534010
GS1
1
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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).
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FDA Product Code

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Product Code Product Code Name
OEE Diagnostic Low Electric Field
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
October 02, 2014

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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