TREMETRICS

GUDID 04260176127369

MAICO Diagnostics GmbH

Pure-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