Sentiero Desktop Diagnostic

GUDID 04260223145292

Sentiero Desktop Easy Diag Set Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 2. USB data cable AN100418 3. Headphone DD-45 AN100306 4. Probe EP-TY long AN100188-US 5. FW Screening Tymp class 1 AN100561 6. Mira PC Patient Management Software 7. Software label printer AN100414 8. Accessory box for Tymp probe AN100587 9. Accessory box Sentiero (Grason) AN100734 10. Power supply Senti / Sentiero Desktop FW7662M AN100524 11. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS. AN100525-USA/-UK/-EU/-AUS 12. Test cavity tymp AN100549

PATH medical GmbH

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• Primary Device ID: 04260223145292
• NIH Device Record Key: 67044479-64d7-47bb-8f9b-0ea67fe33cb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentiero Desktop Diagnostic
• Version Model Number: 100497-ED
• 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	04260223145292 [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 Desktop Diagnostic]

• 04260223141584: Sentiero Desktop Screening TY / Diagnostic Set US13 Content: 1. Carton for Sentiero Desktop AN10
• 04260223141577: Sentiero Desktop Screening TY / Diagnostic Set US12 Content: 1. Carton for Sentiero Desktop AN10
• 04260223141560: Sentiero Desktop Screening TY / Diagnostic Set US11 Content: 1. Carton for Sentiero Desktop AN10
• 04260223141553: Sentiero Desktop Diagnostic Set US9 Diagnostic OAE with Diagnostic Tymp, Audio, DPOAE Threshold
• 04260223141546: Sentiero Desktop Diagnostic Set US8 Diagnostic Tymp with Diagnostic OAE and DPOAE threshold esti
• 04260223141539: Sentiero Desktop Diagnostic Set US7 Diagnostic Tymp with Diagnostic OAE Content: 1. Sentiero Des
• 04260223141522: Sentiero Desktop Diagnostic Set US6 Tymp with IPSI, CONTRA, Reflex decay ETF Content: 1. Sentier
• 04260223145308: Sentiero Desktop Diagnostic Starter Kit Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-
• 04260223145292: Sentiero Desktop Easy Diag Set Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 2. USB