DEVICE: Neuroline Twisted Pair SubdermalNeurology Needle Electrodes (05707480038909)

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Device Identifier (DI) Information

Neuroline Twisted Pair SubdermalNeurology Needle Electrodes
74612-200/2/20
74612-200/2/20
Ambu A/S
05707480038909
GS1
1
Ambu Neuroline Twisted Part Subdermal Needle Electrode Length: 12 mm (0.5") Leadwire Length: 200 cm (80") Black is paired with 5 different colours (purple, grey, dark red, pink, beige) 2 x 10 pairs of needles/2 pouches/1 box
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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
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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FDA Product Code

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Product Code Product Code Name
IKT Electrode, needle, diagnostic electromyograph
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 10 and 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Length: 200 Centimeter
Length: 12 Millimeter
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Device Status

In Commercial Distribution
September 22, 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
05707480038916 20 05707480038909 In Commercial Distribution
05707480038923 8 05707480038916 In Commercial Distribution
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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

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+14107686464
Purchase_orders@ambuUSA.com
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