DEVICE: Newsound (06945936702977)
Device Identifier (DI) Information
Newsound
CH22
In Commercial Distribution
Xiamen New Sound Technology Co., Ltd.
CH22
In Commercial Distribution
Xiamen New Sound Technology Co., Ltd.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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? |
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41191 | Audiometer testing system |
An assembly of electronic reference devices intended to calibrate and/or test the calibration of an audiometer. It measures the sound frequency and intensity characteristics that emanate from an audiometer earphone and/or the environment (ambient noise). The system typically consists of an acoustic cavity of known volume, a sound level meter, a microphone with calibration, oscillators, frequency counters, microphone amplifiers, and a recorder. It can measure selected audiometer test frequencies at a given intensity level, and selectable audiometer attenuation settings at a given test frequency.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MDL | Implant, Transmandibular |
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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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0e0699e0-92fc-4e08-90ae-81c8fd21fba0
December 23, 2019
3
September 01, 2016
December 23, 2019
3
September 01, 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 |
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No Package DIs found |
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
[?]
No Customer Contact currently defined