Ear Probe EP-LT

GUDID 04260223144929

EP-LT ear probe, red connector

PATH medical GmbH

Evoked-potential audiometer

• Primary Device ID: 04260223144929
• NIH Device Record Key: 2c5668db-5829-40fe-8948-2003dd37fe8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ear Probe EP-LT
• Version Model Number: 101021-BL
• 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: false
• 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	04260223144929 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131141

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

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: 2020-04-22
• Device Publish Date: 2020-04-14

On-Brand Devices [Ear Probe EP-LT]

• 04260223144929: EP-LT ear probe, red connector
• 04260223144684: EP-LT ear probe, red connector