Ear Coupler Set

GUDID 04260223143427

Ear Coupler Set (25 pcs.)

PATH medical GmbH

Evoked-potential audiometer

• Primary Device ID: 04260223143427
• NIH Device Record Key: 2d61e943-96f9-40f0-a76e-4571af7c28da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ear Coupler Set
• Version Model Number: 100890-25
• Company DUNS: 551540334
• Company Name: PATH medical GmbH
• Device Count: 25
• 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: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	04260223143410 [Unit of Use]
GS1	04260223143427 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-05
• Device Publish Date: 2018-10-04

On-Brand Devices [Ear Coupler Set]

• 04260223143427: Ear Coupler Set (25 pcs.)
• 04260223143410: Ear Coupler Set (5 pcs.)