FDA.reportPublic FDA data

N/A

Primary DI
EINO5306669
Brand
N/A
Company
inomed Medizintechnik GmbH
Model
530666
Device description
Electrode 15 mm bipolar, 10 pcs.
Published
2016-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ETNStimulator, Nerve
GWFStimulator, Electrical, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
GWFStimulator, Electrical, Evoked ResponseNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EINO5306669PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
340782259
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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04250307606740N/A8990402023-02-03
04250307605606N/A8010002022-09-27
04250307605613N/A8010032022-09-27
04250307605620N/A8010042022-09-27
04250307605637N/A8010052022-09-27
04250307605644N/A8010062022-09-27
04250307605651N/A8010072022-09-27
04250307605668N/A8010082022-09-27
04250307605675N/A8010092022-09-27
04250307605705N/A8010122022-09-27
04250307605736N/A8010152022-09-27
04250307605743N/A8010162022-09-27

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B006EAKITMSP52Dragonfly®Neurovision Medical Products, Inc.ETN2023-03-20
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