DEVICE: Neurosign Disposable Twisted Triple Electrodes (05060229530325)
Device Identifier (DI) Information
Neurosign Disposable Twisted Triple Electrodes
1697-00-TE
Not in Commercial Distribution
THE MAGSTIM COMPANY LIMITED
1697-00-TE
Not in Commercial Distribution
THE MAGSTIM COMPANY LIMITED
20mm x 0.3mm needle electrode; 1m cable with TP DIN42802 connector
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47714 | Subdermal needle electrode |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IKT | Electrode, Needle, Diagnostic Electromyograph |
GXZ | Electrode, Needle |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep away from sunlight |
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity |
Storage Environment Temperature: between 10 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
dc0cf639-6b43-428a-aee0-a9d2f2b5b92c
August 30, 2019
3
September 23, 2016
August 30, 2019
3
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
15060229530322 | 20 | 05060229530325 | 2018-02-25 | Not in Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+441994241111
salesoperations@magstim.com +441994240798
QA.RA@magstim.com
salesoperations@magstim.com +441994240798
QA.RA@magstim.com