Sentiero AuDX 100250-BL-US1

GUDID 04260223143434

Sentiero AuDX Set Content: 1. Sentiero Screening device AN100098-AU 2. Carrying case AN100928 3. Inlay AN100677 4. Probe EP-DP Path long AN100028-US 5

PATH medical GmbH

Evoked-potential audiometer

• Primary Device ID: 04260223143434
• NIH Device Record Key: 1b823347-c052-4701-bec0-416adedd8c48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentiero AuDX
• Version Model Number: 8-04-16500
• Catalog Number: 100250-BL-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	04260223143434 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133012

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

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: 2018-11-21
• Device Publish Date: 2018-06-01

On-Brand Devices [Sentiero AuDX]

• 04260223143441: Sentiero AuDX Set Content: 1. Sentiero Screening device AN100098-AU 2. Carrying case AN100928 3.
• 04260223143434: Sentiero AuDX Set Content: 1. Sentiero Screening device AN100098-AU 2. Carrying case AN100928 3.