Sentiero Screening

GUDID 04260223141423

Sentiero Screening OAE + Audiometry Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Sentiero Screening device

PATH medical GmbH

Evoked-potential audiometer

• Primary Device ID: 04260223141423
• NIH Device Record Key: 079fde34-233a-4498-80fc-51bd8975b602
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentiero Screening
• Version Model Number: 100250-US1
• 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	04260223141423 [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: 4
• Public Version Date: 2019-01-08
• Device Publish Date: 2016-08-31

On-Brand Devices [Sentiero Screening]

• 04260223141423: Sentiero Screening OAE + Audiometry Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3.
• 04260223141416: Sentiero Screening OAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cab