Sentiero Advanced

GUDID 04260223141591

Sentiero Advanced ABR US1 Content: 1. Case AN100503 2. Inlay Sentiero AN100527 3. USB data cable AN100089 4. Path electrodes: 30 pcs. / bag. Each bag

PATH medical GmbH

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• Primary Device ID: 04260223141591
• NIH Device Record Key: 7a1723bf-c3d8-414f-8112-b20c3cc2ea18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentiero Advanced
• Version Model Number: 100340-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	04260223141591 [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: 2017-03-31

On-Brand Devices [Sentiero Advanced]

• 04260223142444: Sentiero Advanced device with touchscreen
• 04260223141621: Sentiero Advanced ABR US4 Content: 1. Case AN100503 2. Inlay Sentiero AN100527 3. USB data cable
• 04260223141614: Sentiero Advanced ABR US3 Content: 1. Case AN100503 2. Inlay Sentiero AN100527 3. USB data cabl
• 04260223141607: Sentiero Advanced ABR US2 Content: 1. Case AN100503 2. Inlay Sentiero AN100527 3. USB data cable
• 04260223141591: Sentiero Advanced ABR US1 Content: 1. Case AN100503 2. Inlay Sentiero AN100527 3. USB data cable
• 04260223143625: Sentiero Advanced ABR US0 Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable
• 04260223145278: Sentiero Advanced Starter Kit Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data c
• 04260223145261: 100340-SC-AT Sentiero Advanced ABR and TEOAE Screening Set Content: 1. Case AN100503 2. Inlay Se
• 04260223145254: Sentiero Advanced ABR and TEOAE Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN1006
• 04260223145247: Sentiero Advanced ABR, OAE, Tympanometry and Audio Screening Set Content: 1. Case AN100503 2. In
• 04260223145230: Sentiero Advanced ABR, OAE, Tympanometry and Audio Screening Set Content: 1. Case AN100503 2. In
• 04260223145223: Sentiero Advanced ABR and DPOAE Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN1006
• 04260223145216: Sentiero Advanced ABR and DPOAE Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN1006
• 04260223145209: Sentiero Advanced Easy Diag Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data
• 04260223143632: Sentiero Advanced ABR Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB
• 04260223146527: Sentiero Advanced ABR and DPOAE Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN1006
• 04260223146718: Sentiero Advanced ABR and DPOAE Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN1006
• 04260223146701: Sentiero Advanced ABR and DPOAE or TEOAE Screening Set Content: 1. Case AN100503 2. Inlay Sentie
• 04260223146695: Sentiero Advanced ABR and DPOAE or TEOAE Screening Set Content: 1. Case AN100503 2. Inlay Sentie