DEVICE: Neurosign Kartush Disposable Surgical Stimulator; Curved Needle (05060229531452)

Device Identifier (DI) Information

Neurosign Kartush Disposable Surgical Stimulator; Curved Needle
4016-00
In Commercial Distribution

THE MAGSTIM COMPANY LIMITED
05060229531452
GS1

1
500375274 *Terms of Use
Curved needle and 3m extension cable DIN42802 to DIN42802
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Nerve-locating probe, single-use A 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.
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FDA Product Code

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Product Code Product Code Name
ETN Stimulator, Nerve
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

17e3d3d7-ecbd-40a3-832d-c9fc8afadb3c
March 29, 2018
2
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+441994241111
salesoperations@magstim.com
+441994240798
QA.RA@magstim.com
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