Ear Coupler Set

GUDID 04260223143410

Ear Coupler Set (5 pcs.)

PATH medical GmbH

Evoked-potential audiometer

• Primary Device ID: 04260223143410
• NIH Device Record Key: 84b2719a-6aec-4dba-907e-2ac1ffe08e8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ear Coupler Set
• Version Model Number: 100890-5
• Company DUNS: 551540334
• Company Name: PATH medical GmbH
• Device Count: 5
• 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	04260223145315 [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: 2020-07-06
• Device Publish Date: 2020-06-27

On-Brand Devices [Ear Coupler Set]

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