Bone Conductor (BC-2) 041545

GUDID 05713315009969

BC-2 Bone Conductor With Headband

Gn Otometrics A/S

Pure-tone audiometer

• Primary Device ID: 05713315009969
• NIH Device Record Key: 88b1e59f-388e-48af-87da-0e704e855b0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Conductor (BC-2)
• Version Model Number: 041545
• Catalog Number: 041545
• 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	05713315009969 [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