FDA.reportPublic FDA data

Natus

Primary DI
00382830043809
Brand
Natus
Company
NATUS NEUROLOGY INCORPORATED
Model
085-462401
Device description
Nicolet EEG Patient Event Button
Published
2021-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180181000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180181000Natus QuantumNatus Medical Incorporated Dba Excel_Tech Ltd. (Xltek)2018-02-22GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830043809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830043809003828300438093828300438090382830043809

GMDN Terms#

Term, Definition table
TermDefinition
Analytical non-scalp cutaneous leadAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
874257488
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382830029131NATUS NEUROLOGY S-019-4749002016-09-15
00382830051910Natus0487782026-02-18
00382830038751Natus 041-7040002016-09-15
00382830032759Natus982A05972025-02-06
00382830032872Natus982A05692025-02-06
00382830034357Natus842-6483002025-02-06
00382830034395Natus842-6479002025-02-06
00382830035002Natus828-0697002025-02-06
00382830035019Natus828-0695002025-02-06
00382830035026Natus828-0694002025-02-06
00382830035033Natus828-0693002025-02-06
00382830036153Natus688-6286002025-02-06
00382830036160Natus688-6285002025-02-06
00382830044998Natus0469582025-02-06
00382830045070Natus688-6303002025-02-06
00382830045087Natus688-6304002025-02-06
00382830046916Natus0176062025-02-06
00382830046930Natus0176082025-02-06
00382830046947Natus017609 2025-02-06
00382830051385Natus0433122025-02-06

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