DEVICE: NATUS NEUROLOGY (00382830034432)

Device Identifier (DI) Information

NATUS NEUROLOGY
842-507400
In Commercial Distribution

NATUS NEUROLOGY INCORPORATED
00382830034432
GS1

1
874257488 *Terms of Use
TIP 4MM INFANT EARTIPS (10PR)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Earphone, insert An electroacoustic device intended to be worn in the ear to transmit sound to the ear from an external device for improved hearing or private listening. It is designed to fit either in the outer ear or is attached directly to a connecting element such as an earmould inserted in the ear canal.
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FDA Product Code

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Product Code Product Code Name
GWJ Stimulator, Auditory, Evoked Response
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K965065 000
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Sterilization

No
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

be966c1e-3b26-4666-b386-50869734ba20
July 06, 2018
3
September 16, 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)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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