Bone Conductor B81

GUDID 04260223143113

Bone conductor for Sentiero

PATH medical GmbH

Evoked-potential audiometer

• Primary Device ID: 04260223143113
• NIH Device Record Key: 32021c9c-cf8c-44a7-813d-dc22ccef15b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Conductor B81
• Version Model Number: 100909
• Company DUNS: 551540334
• Company Name: PATH medical GmbH
• 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
GS1	04260223143113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133012

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-31

On-Brand Devices [Bone Conductor B81]

• 04260223143120: Bone conductor with patient response button for Sentiero
• 04260223143113: Bone conductor for Sentiero
• 04260223143106: Bone conductor for Sentiero Advanced / Sentiero Desktop