SIGNIA

Basic Information

• Brand Name: SIGNIA
• Primary DI: 05714880211504
• Version / Model: CROS Styletto IX
• Catalog Number: 21029375
• Company Name: Ws Audiology Usa, Inc.
• Labeler DUNS: 157412271
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-28
• Public Version: 1
• Public Version Date: 2024-03-07
• Public Version Status: New
• Public Device Record Key: a97dce6b-4ccc-45f2-8cb9-486038b0dcb0

Device Description

SET CROS STYLETTO IX BLK GPH

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Manufacturing Date: No
• 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
OSM	Hearing Aid, Air Conduction With Wireless Technology	Ear, Nose, Throat	874.3305	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59460	Contralateral hearing unit	A passive (i.e., non-powered) acoustic device intended to compensate for total hearing loss in one ear, by transmitting sound received by a microphone from the deaf ear to an active (i.e., powered) hearing aid worn on the hearing ear. This contralateral routing of sound (CROS) technology is designed to improve awareness of sounds (e.g., traffic, speech) emanating from all directions. The device typically consists of a microphone contained in a case worn behind-the-ear (BTE) with a connection cable. The cable both transmits the power from, and the signal to, the active hearing aid.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05714880211504	GS1

Customer Contacts

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