DEVICE: Neuroline SubdermalNeurology Needle Electrodes (05707480121380)

Device Identifier (DI) Information

Neuroline SubdermalNeurology Needle Electrodes
74512-150/24G
Not in Commercial Distribution
74512-150/24G
Ambu A/S
05707480121380
GS1
March 09, 2018
1
305682023 *Terms of Use
Ambu Neuroline Subdermal - Green wires only - USA
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Device Characteristics

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

GMDN

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

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Size Type Text
Length: 12 Millimeter
Length: 150 Centimeter
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Device Record Status

f72f55db-bdee-4a17-af24-8c7a8a12ca15
March 29, 2018
2
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
05707480121403 16 05707480121397 2018-03-09 Not in Commercial Distribution
05707480121397 24 05707480121380 2018-03-09 Not 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)

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No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+14107686464
Purchase_orders@ambuUSA.com
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