FDA.reportPublic FDA data

Sierra II

Primary DI
00840067102022
Brand
Sierra II
Company
CADWELL INDUSTRIES, INC.
Model
190140-200
Device description
Sierra II Handheld Stim w/Optical Control
Published
2016-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWEStimulator, photic, evoked response
GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE
GWJSTIMULATOR, AUDITORY, EVOKED RESPONSE
GWQFull-montage Standard Electroencephalograph
IKNElectromyograph, diagnostic
JXEDEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT
OLTNon-normalizing quantitative electroencephalograph software
OLVStandard polysomnograph with electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWEStimulator, Photic, Evoked ResponseNeurology2
GWFStimulator, Electrical, Evoked ResponseNeurology2
GWJStimulator, Auditory, Evoked ResponseNeurology2
GWQFull-Montage Standard ElectroencephalographNeurology2
IKNElectromyograph, DiagnosticPhysical Medicine2
JXEDevice, Nerve Conduction Velocity MeasurementNeurology2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2
OLVStandard Polysomnograph With ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840067102022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840067102022008400671020228400671020220840067102022

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

Contacts#

Phone, Email table
PhoneEmail
+1(509)735-6481applications@cadwell.com

Regulatory Flags#

DUNS number
098554157
Device count
1
DM exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840067102176Cadwell Patch Electrode with Snap Connector302699-2002018-11-28
00840067102183Cadwell Patch Electrode with Snap Connector302698-2002018-11-28
00840067102206Cadwell Patch Electrode with Snap Connector302696-2002018-11-29
00840067102497Cadwell Patch Electrode with Snap Connector302696-0002017-12-22
00840067104224Cadwell190306-200-COR2026-03-02
00840067104200Cadwell190306-200-TST2026-03-01
00840067104217Cadwell190306-200-LEG2026-03-01
00840067102954Cadwell302767-2002024-06-30
00840067103944Cadwell302553-200-00002022-03-15
00840067103364Cadwell302556-200-90802021-12-15
00840067103722Cadwell302515-200-04802021-12-15
00840067103746Cadwell302516-200-02802021-12-15
00840067102503ApneaTrak190306-2002019-04-15
00840067104149Cadwell BlueBird302501-200-0302025-12-31
00840067104163Cadwell BlueBird302501-200-0402025-12-31
00840067104187Cadwell BlueBird302501-200-0502025-12-31
00840067102305Cadwell Bar302146-2002025-12-31
00840067103005Cadwell302692-2002025-12-31
00840067103029Zenith199355-2002025-12-31
00840067104132Cadwell BlueBird302501-200-0302025-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720256698296Onera STS 2Onera B.V.OLV2026-05-15
08056446900338NeMus 2 600EB NEURO SPAGWE2025-05-26
08056446900338NeMus 2 600EB NEURO SPAGWF2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWE2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWF2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWF2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWE2025-05-26
08056446901038GOGGLES STIMULATOR IIEB NEURO SPAGWE2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAOLT2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWE2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWJ2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWF2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAIKN2025-05-22
08056446901113NExT-PADEB NEURO SPAOLT2025-05-22
08056446901113NExT-PADEB NEURO SPAGWF2025-05-22
08056446901113NExT-PADEB NEURO SPAIKN2025-05-22
08056446901113NExT-PADEB NEURO SPAGWE2025-05-22
08056446901113NExT-PADEB NEURO SPAGWJ2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWF2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWJ2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAOLT2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWE2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAIKN2025-05-22
08056446901137NExT-HSEB NEURO SPAOLT2025-05-22
08056446901137NExT-HSEB NEURO SPAGWJ2025-05-22
08056446901137NExT-HSEB NEURO SPAGWE2025-05-22
08056446901137NExT-HSEB NEURO SPAIKN2025-05-22
08056446901137NExT-HSEB NEURO SPAGWF2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWF2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWJ2025-05-22