FDA.reportPublic FDA data

N/A

Primary DI
EINO5256039
Brand
N/A
Company
inomed Medizintechnik GmbH
Model
525603
Device description
MS probe length 4.5cm angled monopolar, 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
EINO5256039PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating probe, single-useA sterile, hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG)], by delivering controlled electrical impulses to a specific body site for the measurement of a nerve response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. 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

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04250307605705N/A8010122022-09-27
04250307605736N/A8010152022-09-27
04250307605743N/A8010162022-09-27

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