Phonak Brand

Basic Information

• Brand Name: Phonak Brand
• Primary DI: 07613275561584
• Version / Model: 054-0768
• Catalog Number: 054-0768
• Company Name: Sonova AG
• Labeler DUNS: 480662550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-01
• Public Version: 1
• Public Version Date: 2021-11-09
• Public Version Status: New
• Public Device Record Key: e51d0c36-de57-479f-adc6-805848b04a28

Device Description

EasyView Otoblock M

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: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• 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
ESD	Hearing aid, air conduction	Ear, Nose, Throat	874.3300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43783	Earmould impression kit	A collection of non-sterile supplies, instruments, and materials intended to be used to make an accurate impression of the folds and convolutions of cartilage that form the outer ear and its canal (i.e., an earmould). It typically includes a foam or cotton block, a mixing bowl, a spatula, impression liquid and/or powder; it also includes either a syringe or tube to deliver the impression material, or less frequently an impression tray for direct moulding. The mould of the ear is used to manufacture custom-made hearing devices such as hearing aids and earplugs. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613275561584	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]