Sentiero Desktop Diagnostic

GUDID 04260223141584

Sentiero Desktop Screening TY / Diagnostic Set US13 Content: 1. Carton for Sentiero Desktop AN100728 2. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 3. USB data cable AN100418 4. Probe EP-TY long AN100188-US 5. Headphone DD-45 AN100306 6. FW Screening Tymp class 2 AN100560 7. Pure Tone Audiometer Class 3 set (Sentiero desktop) software, bone conductor & pat. response button AN100588 8. DPOAE Software AN100110 9. TEOAE Software AN100109 10. DPHiRES Software AN100537 11. FMDPOAE Software AN100536 12. PC based Patient Management, Mira Software AN100116 13. Software label printer AN100414 14. Accessory box for Tymp probe AN100587 15. Accessory box Sentiero (Grason) AN100734 16. Power supply Senti / Sentiero Desktop FW7662M AN100524 17. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS. AN100525-USA/-UK/-EU/-AUS 18. Test cavity tymp AN100549

PATH medical GmbH

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• Primary Device ID: 04260223141584
• NIH Device Record Key: 838717b3-aa07-45fb-8abe-f9169b2a174b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentiero Desktop Diagnostic
• Version Model Number: 100497-US13
• 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	04260223141584 [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: 2020-01-31
• Device Publish Date: 2018-03-31

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