AccessGUDID - DEVICE: NeviFile kit US (07350094440279)

GUDID

Device Identifier (DI) Information

Brand Name: NeviFile kit US
Version or Model: 142-0013
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 142-0013
Company Name: Scibase AB

Primary DI Number: 07350094440279
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 776863743 *Terms of Use

Device Description: NeviFile is a software application that can be installed on a computer, to be used as an accessory to Nevisense. NeviFile is used for printing reports as well as saving reports for viewing. NeviFile is also needed to be able to print reports from Nevisense via network, immediately when an examination iscompleted and a report is created.

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:	Yes
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	002

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: 39c4780e-04bf-41a8-889b-6e960770c6d2
Public Version Date: January 03, 2024
Public Version Number: 3
DI Record Publish Date: January 30, 2019