TREMETRICS

GUDID 04260176127369

MAICO Diagnostics GmbH

Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer

• Primary Device ID: 04260176127369
• NIH Device Record Key: ae15a858-b14f-4f14-9e1e-7649006068a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TREMETRICS
• Version Model Number: RA360
• Company DUNS: 344863550
• Company Name: MAICO Diagnostics GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260176127369 [Primary]

FDA Product Code

• EWO: Audiometer

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: 2020-07-16
• Device Publish Date: 2020-07-08

Devices Manufactured by MAICO Diagnostics GmbH

• 04260176128304 - Benson: 2024-01-22
• 04260176128311 - Benson: 2024-01-15
• 04260176127444 - Maico: 2022-06-23
• 04260176129431 - Maico: 2022-06-23
• 04260176127628 - Benson: 2021-02-23
• 04260176127635 - Benson: 2021-02-23
• 04260176127659 - Benson: 2021-02-23
• 04260176127666 - Benson: 2021-02-23