Sentiero Desktop Screening

GUDID 04260223141485

Sentiero Desktop Screening Set US2 Content: 1. Sentiero Desktop (Tymp Screening) AN100434-SB 2. USB data cable AN100418 3. Probe EP-TY long AN100188-U

PATH medical GmbH

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• Primary Device ID: 04260223141485
• NIH Device Record Key: 2b065c42-3438-4173-83af-671d88d81340
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentiero Desktop Screening
• Version Model Number: 100497-US2
• 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	04260223141485 [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

On-Brand Devices [Sentiero Desktop Screening]

• 04260223141515: Sentiero Desktop Screening Set US5 Screening OAE with Screening Tymp (IPSI&CONTRA) & Screening A
• 04260223141508: Sentiero Desktop Screening Set US4 Screening OAE with Screening Tymp (IPSI only) Content: 1. Sen
• 04260223141492: Sentiero Desktop Screening Set US3 Content: 1. Sentiero Desktop (Tymp Screening) AN100434-SB 2.
• 04260223141485: Sentiero Desktop Screening Set US2 Content: 1. Sentiero Desktop (Tymp Screening) AN100434-SB 2.
• 04260223141478: Sentiero Desktop Screening Set US1 Sentiero Desktop Screening Set Tymp with IPSI Reflex Content: