Newsound

Basic Information

• Brand Name: Newsound
• Primary DI: 06945936702984
• Version / Model: CH33
• Company Name: Xiamen New Sound Technology Co., Ltd.
• Labeler DUNS: 528181200
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 3
• Public Version Date: 2019-12-23
• Public Version Status: Update
• Public Device Record Key: c8be8f52-6e3f-4063-a647-9de0481742e0

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MDL	Implant, Transmandibular	Dental	872.4760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06945936702984	GS1