FDA.reportPublic FDA data

N/A

Primary DI
EINO2307679
Brand
N/A
Company
inomed Medizintechnik GmbH
Model
230767
Device description
MicroMacroElectrode 0.8 mm with depth stop., 5 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
GZLElectrode, Depth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZLElectrode, DepthNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EINO2307679PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Subdermal needle electrodeA sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use 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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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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Primary DI, Brand, Company table
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