Bone Conductor (BC-2) 041546

GUDID 05713315010101

BC-2 Receiver Spare Part Kit

Gn Otometrics A/S

Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer

• Primary Device ID: 05713315010101
• NIH Device Record Key: c8e64a00-3e85-4bf4-a15b-995e920ee35c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Conductor (BC-2)
• Version Model Number: 041546
• Catalog Number: 041546
• Company DUNS: 306633756
• Company Name: Gn Otometrics A/S
• 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: true
• Serial Number: false
• 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
GS1	05713315010101 [Primary]

FDA Product Code

• EWO: Audiometer

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: 2023-03-17
• Device Publish Date: 2023-03-09

On-Brand Devices [Bone Conductor (BC-2)]

• 05713315010101: BC-2 Receiver Spare Part Kit
• 05713315009969: BC-2 Bone Conductor With Headband