DEVICE: Teca Elite (00382830017510)

Device Identifier (DI) Information

Teca Elite
S53158
In Commercial Distribution

NATUS MANUFACTURING LIMITED
00382830017510
GS1

1
896421240 *Terms of Use
TECA ELITE Disposable Concentric Blue Needle, 50mm, .46(26G) diameter, 25 per Pk
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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
Electromyographic needle electrode, single-use A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. 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 [?]
K112034 000
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

6ed65cd1-84da-4954-a26f-9f676c78a35e
July 06, 2018
4
August 25, 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

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No Customer Contact currently defined
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