AccessGUDID - DEVICE: Isolation Transformer ‘GP’ 220-240 VAC 50/60 Hz (08056446900666)

GUDID

Device Identifier (DI) Information

Brand Name: Isolation Transformer ‘GP’ 220-240 VAC 50/60 Hz
Version or Model: B9700041000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EB NEURO SPA

Primary DI Number: 08056446900666
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 339182263 *Terms of Use

Device Description: Isolation Transformer for EEG/EMG/EP systems

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?
16933	Constant-voltage transformer	A device designed to deliver a fixed, predetermined voltage that is one of a limited range of input voltage variations. The device receives a fluctuating input voltage and transforms this fluctuating voltage into a steady (constant) output helping to avoid such fluctuations which are present in the electrical system. These fluctuations may be known as spikes, and can be harmful to devices with sensitive electronics. This device may be inserted into new or existing electrical systems.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKN	Electromyograph, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K073415	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: 7274fa49-51ad-41c9-aac2-8cbdf62eb8b8
Public Version Date: June 03, 2019
Public Version Number: 1
DI Record Publish Date: May 24, 2019