AccessGUDID - DEVICE: Margin Probe Console 1.2R (07290012534058)

GUDID

Device Identifier (DI) Information

Brand Name: Margin Probe Console 1.2R
Version or Model: SA0590020
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DILON MEDICAL TECHNOLOGIES LTD

Primary DI Number: 07290012534058
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600832361 *Terms of Use

Device Description: 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.

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63373	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.	Active	false

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: No
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: 87ced7df-251c-4e99-b7f3-002543e6ba6b
Public Version Date: March 28, 2023
Public Version Number: 1
DI Record Publish Date: March 20, 2023