DEVICE: Newsound (06945936702977)

Device Identifier (DI) Information

Newsound
CH22
In Commercial Distribution

Xiamen New Sound Technology Co., Ltd.
06945936702977
GS1

1
528181200 *Terms of Use
No description.
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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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MDL Implant, Transmandibular
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

0e0699e0-92fc-4e08-90ae-81c8fd21fba0
December 23, 2019
3
September 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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
Yes
No
Yes
Yes CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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