REXTON 10996094

GUDID 04056839087428

S_ITE M-CORE IX-CIC 80DEMO TRD

Ws Audiology Usa, Inc.

Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear

• Primary Device ID: 04056839087428
• NIH Device Record Key: 2d6e1b41-0f7b-4179-a698-da7764546ede
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REXTON
• Version Model Number: M-Core iX-CIC SDemo
• Catalog Number: 10996094
• Company DUNS: 157412271
• Company Name: Ws Audiology Usa, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056839087428 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air Conduction With Wireless Technology

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-25
• Device Publish Date: 2024-03-17

On-Brand Devices [REXTON]

• 05714880196689: HA BICORE B-LI M RUGGED 80 RC8
• 05714880196672: HA BICORE B-LI M RUGGED 80 RC7
• 05714880196665: HA BICORE B-LI M RUGGED 80 RC6
• 05714880196658: HA BICORE B-LI M RUGGED 80 RC5
• 05714880196641: HA BICORE B-LI M RUGGED 80 RC4
• 05714880196634: HA BICORE B-LI M RUGGED 80 RC3
• 05714880196627: HA BICORE B-LI M RUGGED 80 RC2
• 05714880196610: Rexton HA BICORE B-LI M RUGGED 80 RC1 Hearing Aid
• 05714880196603: HA BICORE B-LI M RUGGED 60 RC8
• 05714880196597: HA BICORE B-LI M RUGGED 60 RC7
• 05714880196580: HA BICORE B-LI M RUGGED 60 RC6
• 05714880196573: HA BICORE B-LI M RUGGED 60 RC5
• 05714880196566: HA BICORE B-LI M RUGGED 60 RC4
• 05714880196559: HA BICORE B-LI M RUGGED 60 RC3
• 05714880196542: HA BICORE B-LI M RUGGED 60 RC2
• 05714880196535: HA BICORE B-LI M RUGGED 60 RC1
• 05714880196528: HA BICORE B-LI M RUGGED 40 RC8
• 05714880196511: HA BICORE B-LI M RUGGED 40 RC7
• 05714880196504: HA BICORE B-LI M RUGGED 40 RC6
• 05714880196498: HA BICORE B-LI M RUGGED 40 RC5
• 05714880196481: HA BICORE B-LI M RUGGED 40 RC4
• 05714880196474: HA BICORE B-LI M RUGGED 40 RC3
• 05714880196467: HA BICORE B-LI M RUGGED 40 RC2
• 05714880196450: HA BICORE B-LI M RUGGED 40 RC1
• 05714880194401: SERV. NT BASE BICORE B M 30
• 05714880193992: HA BICORE B M 30 BLK
• 05714880193985: HA BICORE B M 30 GNT
• 05714880193978: HA BICORE B M 30 DKC
• 05714880193961: HA BICORE B M 30 SLV
• 05714880193954: HA BICORE B M 30 GR
• 05714880193947: HA BICORE B M 30 PRL
• 05714880193930: HA BICORE B M 30 DBR
• 05714880193923: HA BICORE B M 30 SB
• 05714880193916: HA BICORE B M 30 RGD
• 05714880193909: HA BICORE B M 30 BG
• 05714880193893: HA BICORE B M 20 BG
• 05714880193886: HA BICORE B M 20 BLK
• 05714880193879: HA BICORE B M 20 DBR
• 05714880193862: HA BICORE B M 20 DKC
• 05714880193855: HA BICORE B M 20 GNT
• 05714880193848: HA BICORE B M 20 GR
• 05714880193831: HA BICORE B M 20 PRL
• 05714880193824: HA BICORE B M 20 RGD
• 05714880193817: HA BICORE B M 20 SB
• 05714880193800: HA BICORE B M 20 SLV
• 05714880193794: HA BICORE B M 10 BLK
• 05714880193787: HA BICORE B M 10 DBR
• 05714880193770: HA BICORE B M 10 DKC
• 05714880193763: HA BICORE B M 10 GNT
• 05714880193756: HA BICORE B M 10 GR