TY-MA

GUDID 04260223143700

Tympanometry add-on

PATH medical GmbH

Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer

• Primary Device ID: 04260223143700
• NIH Device Record Key: 8258c58f-3299-4233-9629-a6f67c5425e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TY-MA
• Version Model Number: 100947-N
• 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	04260223143700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133012

FDA Product Code

• ETY: Tester, Auditory Impedance

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: 2022-01-25
• Device Publish Date: 2022-01-17

On-Brand Devices [TY-MA]

• 04260223143601: Tympanometry add-on
• 04260223143700: Tympanometry add-on