AccessGUDID - DEVICE: NATUS NEUROLOGY (00382830029193)

GUDID

Device Identifier (DI) Information

Brand Name: NATUS NEUROLOGY
Version or Model: S-019-420800
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NATUS NEUROLOGY INCORPORATED

Primary DI Number: 00382830029193
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 874257488 *Terms of Use

Device Description: SAMPLE ELC/DISP DISK 2R2B 3M

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Analytical non-scalp cutaneous lead	An insulated metal wire(s) designed to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance]. It is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Analytical non-scalp cutaneous lead

An insulated metal wire(s) designed to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance]. It is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
GXY	Electrode, Cutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 9caaf47f-192a-4043-bc96-fed3b2ac9e68
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016