FDA.reportPublic FDA data

NATUS NEUROLOGY

Primary DI
00382830032162
Brand
NATUS NEUROLOGY
Company
NATUS NEUROLOGY INCORPORATED
Model
DM-515-015300
Device description
NICOLET EDX BASE UNIT - Demo
Published
2016-09-16
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
IKNElectromyograph, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKNElectromyograph, DiagnosticPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112052000CAREFUSION NICOLET EDXCarefusion 209, Inc.2012-03-15GWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830032162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830032162003828300321623828300321620382830032162

GMDN Terms#

Term, Definition table
TermDefinition
ElectromyographA mains electricity (AC-powered) device designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle. The electromyograph (EMG) is typically used in clinical diagnosis of muscular disorders to evaluate muscle weakness and to determine if the weakness is related to the muscles themselves or a problem with the nerves that supply the muscles.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
874257488
Device count
1
Serial number
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376509747SafeOp 3ALPHATEC SPINE, INC.IKN2026-03-24
00763000886790N/aMEDTRONIC XOMED, INC.IKN2025-06-23
08056446901106NExT-DOCKINGEB NEURO SPAIKN2025-05-22
08056446901113NExT-PADEB NEURO SPAIKN2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAIKN2025-05-22
08056446901137NExT-HSEB NEURO SPAIKN2025-05-22
08056446901168NExT-AMPEB NEURO SPAIKN2025-05-22
08056446901199NExT-ASEB NEURO SPAIKN2025-05-22
08056446901205NExT StationEB NEURO SPAIKN2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAIKN2025-05-19
00190376517506SafeOp 3ALPHATEC SPINE, INC.IKN2024-11-12
00190376530024SafeOp 3ALPHATEC SPINE, INC.IKN2024-11-12
B758000VMPLU0ViMove+DORSAVI LTDIKN2023-08-30
00195377153951PULSENuvasive, Inc.IKN2023-07-11
00195377153968PULSENuvasive, Inc.IKN2023-07-11
00195377153975PULSENuvasive, Inc.IKN2023-07-11
00195377060761PULSENuvasive, Inc.IKN2023-07-06
00195377060778PULSENuvasive, Inc.IKN2023-07-06
00195377153807PULSENuvasive, Inc.IKN2023-05-02
00195377153814PULSENuvasive, Inc.IKN2023-05-02
00195377083272NVM5Nuvasive, Inc.IKN2023-04-13
00195377097415NVM5Nuvasive, Inc.IKN2023-04-13
00195377097422NVM5Nuvasive, Inc.IKN2023-04-13
00195377097439NVM5Nuvasive, Inc.IKN2023-04-13
00190376458601SafeOpALPHATEC SPINE, INC.IKN2023-02-12
00190376459035SafeOpALPHATEC SPINE, INC.IKN2023-02-12
00195377108128PULSENuvasive, Inc.IKN2022-06-30
00195377108135PULSENuvasive, Inc.IKN2022-06-30
00195377049131PULSENuvasive, Inc.IKN2022-05-06
00195377049148PULSENuvasive, Inc.IKN2022-05-06