Sentiero Desktop Diagnostic

GUDID 04260223141546

Sentiero Desktop Diagnostic Set US8 Diagnostic Tymp with Diagnostic OAE and DPOAE threshold estimation Content: 1. Sentiero Desktop (Tymp Diagnostic)

PATH medical GmbH

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• Primary Device ID: 04260223141546
• NIH Device Record Key: bfcc48ab-88ac-4da0-a95b-0539fe84f2aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentiero Desktop Diagnostic
• Version Model Number: 100497-US8
• 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: true
• 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	04260223141546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133012

FDA Product Code

• EWO: Audiometer

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: 2016-08-31

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