FDA.reportPublic FDA data

Sierra Ascent

Primary DI
00840067100349
Brand
Sierra Ascent
Company
CADWELL INDUSTRIES, INC.
Model
190277-200
Device description
Sierra Ascent Handheld Stimulator
Published
2016-09-05
Public version status
Update
Distribution status
Not 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
GZPSTIMULATOR, MECHANICAL, EVOKED RESPONSE
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
GZPStimulator, Mechanical, Evoked ResponseNeurology2
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
00840067100349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840067100349008400671003498400671003490840067100349

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
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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

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