FDA.reportPublic FDA data

N/A

Primary DI
EINO5902150
Brand
N/A
Company
inomed Medizintechnik GmbH
Model
590215
Device description
Connection cable
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
EINO5902150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-function monitorA mains electricity (AC-powered) bedside device designed to continuously assess the adequacy of the nerve function of a non-ambulatory patient who requires monitoring (e.g., as a result of trauma, anaesthesia, intervention, evaluation). It typically monitors evoked potential (EP), electromyography (EMG), electroencephalography (EEG) and/or neuromuscular block response. It typically consists of electrodes applied to the patient intended to acquire the neural electrical signal, and a computerized unit to process and display the information; stimulation systems for nerve block and evoked potential evaluation are separate requirements.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
340782259
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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14250307612069N/A5309562025-05-02
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14250307612083N/A5208552025-05-02
04250307604517ISIS5403402022-09-16
04250307612154N/A8030102024-08-15
04250307612161N/A8030112024-08-15
04250307612178N/A8030122024-08-15
04250307612185N/A8030132024-08-15
04250307610402C2 Xplore5404312024-07-26
14250307604323N/A5336662024-07-01
04250307603275N/A5306072023-10-20
04250307604074N/A5327202023-10-20
04250307604081N/A5327222023-10-20
04250307604111N/A5336222023-10-20
04250307604128N/A5336232023-10-20
04250307604135N/A5336242023-10-20
04250307604142N/A5336252023-10-20
04250307604159N/A5336262023-10-20

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