MD

GUDID 06945936703394

Xiamen New Sound Technology Co., Ltd.

Air-conduction hearing aid, behind-the-ear
Primary Device ID06945936703394
NIH Device Record Keyd5064617-221d-47c3-ac6b-65bf782f80f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMD
Version Model NumberMDHearingAid VOLT
Company DUNS528181200
Company NameXiamen New Sound Technology Co., Ltd.
Device Count2
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106945936703394 [Unit of Use]
GS116945936703391 [Primary]

FDA Product Code

ESDHearing Aid, Air Conduction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-19
Device Publish Date2022-09-09

Devices Manufactured by Xiamen New Sound Technology Co., Ltd.

16945936704831 - PowerLix2024-12-19
06945936704742 - Newsound2024-12-06
06945936704759 - Newsound2024-12-06
06945936704766 - Newsound2024-12-06
06945936704773 - Newsound2024-12-06
06945936704780 - Newsound2024-12-06
06945936704797 - Newsound2024-12-06
16945936704060 - Nano2024-05-29

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