FDA.reportPublic FDA data

Disposable Goggle Foam

Primary DI
00840067102244
Brand
Disposable Goggle Foam
Company
CADWELL INDUSTRIES, INC.
Model
197278-000
Device description
Disposable Goggle Foam; 10pk
Published
2017-07-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter
ETNSTIMULATOR, NERVE
GWEStimulator, photic, evoked response
GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE
GWJSTIMULATOR, AUDITORY, EVOKED RESPONSE
GWQFull-montage Standard Electroencephalograph
GZODevice, galvanic skin response measurement
IKNElectromyograph, diagnostic
JXEDEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT
OLTNon-normalizing quantitative electroencephalograph software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
ETNStimulator, NerveEar, Nose, Throat2
GWEStimulator, Photic, Evoked ResponseNeurology2
GWFStimulator, Electrical, Evoked ResponseNeurology2
GWJStimulator, Auditory, Evoked ResponseNeurology2
GWQFull-Montage Standard ElectroencephalographNeurology2
GZODevice, Galvanic Skin Response MeasurementNeurology2
IKNElectromyograph, DiagnosticPhysical Medicine2
JXEDevice, Nerve Conduction Velocity MeasurementNeurology2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162199000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162199000Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.2017-03-02GWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840067102244PrimaryGS10
20840067102248Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840067102244008400671022448400671022440840067102244
2084006710224820840067102248

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.5Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
098554157
Device count
10
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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