Sentiero Screening2

GUDID 04260223145179

Sentiero Screening2 DPOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Sentiero Screening2 device with touchscreen AN100098-S2 5. Probe EP-LT AN101021 6. DPOAE Quick Software AN100110-Quick 7. FMDPOAE Software AN100536 8. Software label printer AN100414 9. Accessory box EP-LT AN101043 10. Power supply Sentiero US AN101013+AN100993-USA

PATH medical GmbH

Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer

• Primary Device ID: 04260223145179
• NIH Device Record Key: d92768e3-b283-472e-8541-15b2912890eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentiero Screening2
• Version Model Number: 100250-SC-D-LT
• 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	04260223145179 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-06
• Device Publish Date: 2020-06-27

On-Brand Devices [Sentiero Screening2]

• 04260223145193: Sentiero Screening2 TEOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data c
• 04260223145186: Sentiero Screening2 TEOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data c
• 04260223145179: Sentiero Screening2 DPOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data c
• 04260223145162: Sentiero Screening2 DPOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data c
• 04260223145155: Sentiero Screening2 Audio and TEOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3.
• 04260223145148: Sentiero Screening2 Audio and TEOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3.
• 04260223145131: Sentiero Screening2 Audio and DPOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3.
• 04260223145124: Sentiero Screening2 Audio and DPOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3.