AccessGUDID - DEVICE: Training electrode Sterile

GUDID

Device Identifier (DI) Information

Brand Name: Training electrode Sterile - 6 pcs
Version or Model: 131-0008
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 131-0008
Company Name: Scibase AB

Primary DI Number: 07350094440217
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 776863743 *Terms of Use

Device Description: Training electrodes, used for Nevisense training and qualification. Each electrode is to be used only on intact, healthy skin on a single person in a single training session. Each electrode can be used up to 50 times. The reason for the higher number (i.e., 50, as compared with 20 for the examination electrode) is that these electrodes are used for training and qualification purposes only.

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):	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?
60474	Neoplasm electrical impedance spectrometer electrode array	An arrangement of multiple electrical conductors intended to be used in conjunction with an electrical impedance (bioimpedance) spectrometer (EIS/BIS) to apply a small electric current to the skin during EIS analysis, typically of neoplastic skin. It is typically a small cover that fits over a probe and may be textured (e.g., with pins) to penetrate the outermost layer of skin. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	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: 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: 500ea5f4-6efe-484f-9b0e-902b6e067fb0
Public Version Date: January 03, 2024
Public Version Number: 6
DI Record Publish Date: November 21, 2017