Intricon 93339-000, 001, 002, 003, 004

GUDID 00858177007298

BTE Wireless Directional Hearing Aid

INTRICON CORPORATION

Behind-the-ear air-conduction hearing aid

• Primary Device ID: 00858177007298
• NIH Device Record Key: 8264b40c-9851-4d25-8754-00e8eb5167bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intricon
• Version Model Number: L155i2
• Catalog Number: 93339-000, 001, 002, 003, 004
• Company DUNS: 002345767
• Company Name: INTRICON CORPORATION
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858177007298 [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: 2020-09-14
• Device Publish Date: 2020-09-04

On-Brand Devices [Intricon]

• 00858177007045: Wireless Hearing Aid
• 00858177007038: Wireless Hearing Aid
• 00858177007014: Hearing Aid Remote Control
• 00858177007007: Wireless Hearing Aid
• 00858177007304: Companion Microphone
• 00858177007298: BTE Wireless Directional Hearing Aid
• 00858177007281: BTE Wireless Omni Hearing Aid
• 00858177007274: BTE Wireless Directional Hearing Aid
• 00858177007267: BTE Wireless, Omni Hearing Aid
• 00858177007588: BTE Wireless Directional Hearing Aid, Light Gray
• 00858177007328: BTE Wireless Directional Hearing Aid, Silver
• 00858177007649: BTE Wireless Directional Hearing Aid
• 00858177007762: BTE A16BLE MP Dir hearing aid
• 00858177007755: BTE A16BLE Omni hearing aid