AccessGUDID - DEVICE: MarginProbe® Probe (07290012534010)

GUDID

Device Identifier (DI) Information

Brand Name: MarginProbe® Probe
Version or Model: AC0300001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DUNE MEDICAL DEVICES LTD

Primary DI Number: 07290012534010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533247359 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

GMDN Preferred Term Name	GMDN Definition
Intraoperative tumour margin analysis probe	A 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.

GMDN Preferred Term Name

GMDN Definition

Intraoperative tumour margin analysis probe

A 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.

FDA Product Code

[?]

Product Code	Product Code Name
OEE	Diagnostic Low Electric Field

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P110014	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1ed39a30-1458-4d83-8c3f-684eef95ba08
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: October 02, 2014