DEVICE: Neuroline Twisted Pair SubdermalNeurology Needle Electrodes (05707480038909)
Device Identifier (DI) Information
Neuroline Twisted Pair SubdermalNeurology Needle Electrodes
74612-200/2/20
In Commercial Distribution
74612-200/2/20
Ambu A/S
74612-200/2/20
In Commercial Distribution
74612-200/2/20
Ambu A/S
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
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 |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 10 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Length: 200 Centimeter |
Length: 12 Millimeter |
Device Record Status
5d2c864d-6bff-43cf-8978-bc579b169d9d
March 29, 2018
2
September 22, 2016
March 29, 2018
2
September 22, 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 |
---|---|---|---|---|---|
05707480038916 | 20 | 05707480038909 | In Commercial Distribution | ||
05707480038923 | 8 | 05707480038916 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
+14107686464
Purchase_orders@ambuUSA.com
Purchase_orders@ambuUSA.com