FDA.report

Sierra Ascent

Primary DI
00840067100141
Brand
Sierra Ascent
Company
CADWELL INDUSTRIES, INC.
Model
190275-200
Device description
Sierra Ascent 2 Ch. Amplifier
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

Related Records

Contact Domains

Product Codes

CodeName
GWJSTIMULATOR, AUDITORY, EVOKED RESPONSE

Product Code Classifications

CodeDeviceSpecialtyClass
GWJStimulator, Auditory, Evoked ResponseNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840067100141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840067100141008400671001418400671001410840067100141

GMDN Terms

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

Contacts

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

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