AccessGUDID - DEVICE: Test Impedance Tool (07350094440101)

GUDID

Device Identifier (DI) Information

Brand Name: Test Impedance Tool
Version or Model: 590-0002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 590-0002
Company Name: Scibase AB

Primary DI Number: 07350094440101
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 776863743 *Terms of Use

Device Description: The Test Impedance Tool is used by system administrator when performing measurement accuracy tests with the Nevisense. A measurement accuracy test should be performed once a month, to ensure that all Nevisense examinations will present correct measurement data.

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?
42183	Neoplasm electrical impedance spectrometer	An electrically-powered instrument intended to measure/map the differences in capacitance and resistance between neoplastic and surrounding normal tissue, using electrical impedance (bioimpedance) spectroscopy (EIS/BIS). It provides real-time, noninvasive, radiation-free measurement and/or imaging of local distributions of tissue electrical impedance by applying and detecting a low-voltage electrical signal through the skin, via cutaneous electrodes, and displaying the results on a built-in or external screen (e.g., monitor, tablet). It is used for the detection of neoplastic skin and breast cancer, typically in combination with other methodologies (e.g., mammography, visual examination).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ONV	Electrical Impedance Spectrometer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P150046	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: 954f440d-4a9b-457a-9d18-fcbf69d550b2
Public Version Date: February 06, 2025
Public Version Number: 7
DI Record Publish Date: November 21, 2017