FDA.reportPublic FDA data

Sierra Ascent

Primary DI
00840067100134
Brand
Sierra Ascent
Company
CADWELL INDUSTRIES, INC.
Model
190273-200
Device description
Sierra Ascent Base
Published
2016-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLTNon-normalizing quantitative electroencephalograph software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840067100134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840067100134008400671001348400671001340840067100134

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
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840067104224Cadwell190306-200-COR2026-03-02
00840067104200Cadwell190306-200-TST2026-03-01
00840067104217Cadwell190306-200-LEG2026-03-01
00840067102305Cadwell Bar302146-2002025-12-31
00840067103005Cadwell302692-2002025-12-31
00840067103029Zenith199355-2002025-12-31
00840067104132Cadwell BlueBird302501-200-0302025-12-31
00840067104156Cadwell BlueBird302501-200-0402025-12-31
00840067104170Cadwell BlueBird302501-200-0502025-12-31
00840067103555Cadwell Guardian199334-000-0082024-11-15
00840067103562Cadwell Guardian199335-000-0082024-11-15
00840067103623Cadwell Guardian199335-000-0032024-11-15
00840067103630Cadwell Guardian199334-000-0032024-11-15
00840067103982Sierra Summit190317-2002024-11-15
00840067102992Cadwell Guardian199321-2002024-08-23
10840067103996Cadwell197342-0002024-08-23
00840067102954Cadwell302768-2002024-06-30
00840067102961Cadwell302767-2002024-06-30
00840067104040Cadwell302055-2002024-06-30
00840067104057Cadwell302058-2002024-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860410000379Q21NEUROFIELD, INC.OLT2025-06-02
10840067103996CadwellCADWELL INDUSTRIES, INC.OLT2024-08-23
10841522108754UltraviewSLSPACELABS HEALTHCARE (WASHINGTON), INCOLT2024-05-13
00195278466662E-EEGXGE Healthcare Finland OyOLT2022-07-01
00841983104329NeurofaxNIHON KOHDEN AMERICA, INC.OLT2021-08-06
05694110068057Stratus EEGKvikna Medical ehf.OLT2021-01-28
05694110068064Stratus EEGKvikna Medical ehf.OLT2021-01-28
05694110068071Stratus EEGKvikna Medical ehf.OLT2021-01-28
B485VIS100CNS EnvisionMOBERG RESEARCH INCOLT2020-10-28
05694110068040Stratus EEGKvikna Medical ehf.OLT2020-09-01
04931921009161NeurofaxNIHON KOHDEN CORPORATIONOLT2020-03-24
04931921007723Nihon Kohden, EEG-1200A Series NeurofaxNIHON KOHDEN CORPORATIONOLT2019-07-24
04931921007730Nihon Kohden, EEG-1200A Series NeurofaxNIHON KOHDEN CORPORATIONOLT2019-07-24
04931921007631Nihon Kohden, EEG-1200A Series NeurofaxNIHON KOHDEN CORPORATIONOLT2019-07-24
04931921007716Nihon Kohden, EEG-1200A Series NeurofaxNIHON KOHDEN CORPORATIONOLT2019-07-24
00840067102718Cascade IOMAX Intraoperative MonitorCADWELL INDUSTRIES, INC.OLT2019-07-09
00840067102688IOMAX AdapterCADWELL INDUSTRIES, INC.OLT2019-05-13
00869732000135Persyst Mobile App PERSYST DEVELOPMENT CORPOLT2019-04-08
00840067102251ApolloCADWELL INDUSTRIES, INC.OLT2018-08-21
B485CNSINX3001Component Neuromonitoring SystemMOBERG RESEARCH INCOLT2018-06-06
B485CNSINX3201Component Neuromonitoring SystemMOBERG RESEARCH INCOLT2018-06-06
B485CNS3101Component Neuromonitoring SystemMOBERG RESEARCH INCOLT2017-12-21
05694110063090Lifelines iEEGKvikna Medical ehf.OLT2017-11-09
04931921004357NANIHON KOHDEN CORPORATIONOLT2017-09-27
00840067102244Cadwell Disposable Goggle FoamCADWELL INDUSTRIES, INC.OLT2017-07-11
00841983104008Polysmith Sleep SystemNIHON KOHDEN AMERICA, INC.OLT2017-05-24
00841983103995NANIHON KOHDEN AMERICA, INC.OLT2017-05-17
00841983103988NeurofaxNIHON KOHDEN AMERICA, INC.OLT2017-04-26
00841983103971NEUROFAXNIHON KOHDEN AMERICA, INC.OLT2016-11-18
05694110063052Lifelines iEEG Client SoftwareKvikna Medical ehf.OLT2016-10-03