FDA.reportPublic FDA data

Natus

Primary DI
00382830043397
Brand
Natus
Company
XLTEK
Model
10440
Device description
NATUS PHOTIC STIM  
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
GWEStimulator, Photic, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWEStimulator, Photic, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991903000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991903000EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)Excel Tech. , Ltd.1999-08-04GWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830043397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830043397003828300433973828300433970382830043397

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
245258280
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382830023955Natus20130012025-02-27
00382830023986Natus20400012025-02-27
00382830059251Natus20200112025-02-27
00382830062466Natus60-0000702024-09-30
00382830016896Natus61-0004002021-06-22
00382830056335Natus61-0003002021-06-22
00382830058674Natus60-0000902021-06-22
00382830058681Natus60-0000922021-06-22
00382830060110NatusRETCAM-FA-UPGRADE2021-06-22
00382830002424Natus103282016-09-13
00382830002950Natus103592016-09-13
00382830003063Natus1027622016-09-13
00382830003155Natus1040372016-09-13
00382830022316GrassCMXL-PLUS-ECMXL-PLUS-E2018-07-13
00382830022323GrassCMXL-E-SPCCMXL-E-SPC2018-07-13
00382830022330GrassCMXL-E-APCCMXL-E-APC2018-07-13
00382830022347GrassCM-PLUS-ECM-PLUS-E2018-07-13
00382830022392GrassCMXL-PLUS-PCMXL-PLUS-P2018-07-13
00382830022408GrassCMXL-P-NCCMXL-P-NC2018-07-13
00382830022415GrassCMXL-P-APCCMXL-P-APC2018-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08056446900345NeMus 2 700EB NEURO SPAGWE2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWE2025-05-26
08056446901038GOGGLES STIMULATOR IIEB NEURO SPAGWE2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWE2025-05-22
08056446901113NExT-PADEB NEURO SPAGWE2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWE2025-05-22
08056446901137NExT-HSEB NEURO SPAGWE2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWE2025-05-22
08056446901199NExT-ASEB NEURO SPAGWE2025-05-22
08056446901205NExT StationEB NEURO SPAGWE2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWE2025-05-19
08056446900185USB FLASH ADAPTER CABLE L=3mEB NEURO SPAGWE2024-12-04
08056446900192USB FLASH ADAPTER CABLE L=5mEB NEURO SPAGWE2024-12-04
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00840067102879Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
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00840067102893Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102909Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102916Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04