audifon 020715-7682-3120-1720

GUDID EADF0207157682312017201

BTE-TRT

audifon GmbH & Co. KG

Behind-the-ear air-conduction hearing aid Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear

• Primary Device ID: EADF0207157682312017201
• NIH Device Record Key: ff16c9a9-3ff3-405a-99f8-db8de224278b
• Commercial Distribution Discontinuation: 2016-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: audifon
• Version Model Number: elia XS TRT
• Catalog Number: 020715-7682-3120-1720
• Company DUNS: 344064407
• Company Name: audifon GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EADF0207157682312017201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130514

FDA Product Code

• KLW: Masker, Tinnitus

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-22
• Device Publish Date: 2016-11-18

On-Brand Devices [audifon]

• EADF019023700033517201: BTE-TRT
• EADF019023700032517201: BTE-TRT
• EADF019023700032117201: BTE-TRT
• EADF019023700031517201: BTE-TRT
• EADF019023700031317201: BTE-TRT
• EADF019023700031117201: BTE-TRT
• EADF004032290933517201: BTE-TRT
• EADF004032290932517201: BTE-TRT
• EADF004032290932117201: BTE-TRT
• EADF004032290931517201: BTE-TRT
• EADF004032290931317201: BTE-TRT
• EADF004032290931117201: BTE-TRT
• EADF0253819507338217201: RITE Tinnitus
• EADF0253819507338117201: RITE Tinnitus
• EADF025381950733217201: RITE Tinnitus
• EADF025381950732517201: RITE Tinnitus
• EADF0253819507315917201: RITE Tinnitus
• EADF025381950731317201: RITE Tinnitus
• EADF0253819507312717201: RITE Tinnitus
• EADF025381950731217201: RITE Tinnitus
• EADF0253819507312017201: RITE Tinnitus
• EADF0231759047338217201: RITE-TRT
• EADF0231759047338117201: RITE-TRT
• EADF023175904733217201: RITE-TRT
• EADF023175904732517201: RITE-TRT
• EADF0231759047315917201: RITE-TRT
• EADF023175904731317201: RITE-TRT
• EADF0231759047312717201: RITE-TRT
• EADF023175904731217201: RITE-TRT
• EADF0231759047312017201: RITE-TRT
• EADF0231749046338217201: BTE-TRT
• EADF0231749046338117201: BTE-TRT
• EADF023174904633217201: BTE-TRT
• EADF023174904632517201: BTE-TRT
• EADF0231749046315917201: BTE-TRT
• EADF023174904631317201: BTE-TRT
• EADF0231749046312717201: BTE-TRT
• EADF023174904631217201: BTE-TRT
• EADF0231749046312017201: BTE-TRT
• EADF0231739045338217201: BTE-TRT
• EADF0231739045338117201: BTE-TRT
• EADF023173904533217201: BTE-TRT
• EADF023173904532517201: BTE-TRT
• EADF0231739045315917201: BTE-TRT
• EADF023173904531317201: BTE-TRT
• EADF0231739045312717201: BTE-TRT
• EADF023173904531217201: BTE-TRT
• EADF0231739045312017201: BTE-TRT
• EADF0231729044338217201: BTE-TRT
• EADF0231729044338117201: BTE-TRT