DEVICE: Neuroline SubdermalNeurology Needle Electrodes (05707480024162)

Download: XML | JSON

Device Identifier (DI) Information

Neuroline SubdermalNeurology Needle Electrodes
74512-100/24
74512-100/24
Ambu A/S
05707480024162
GS1
1
Needle Electrode Length: 12 mm (0.5") Leadwire Length: 100 cm (40") Each box of 24 consists of 4 pieces in each of the colors: White, Green, Blue, Yellow, Red, Black
CLOSE

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
IKT Electrode, needle, diagnostic electromyograph
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 40 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 100 Centimeter
Length: 12 Millimeter
CLOSE

Device Status

In Commercial Distribution
September 22, 2016
March 16, 2022
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05707480003303 16 05707480023219 2017-03-16 Not in Commercial Distribution
05707480023219 24 05707480024162 2017-03-16 Not in Commercial Distribution
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+14107686464
Purchase_orders@ambuUSA.com
CLOSE