earflex yellow 25 shore 8x50ml

GUDID EDET038901

DETAX GmbH

Earmould, custom-made

• Primary Device ID: EDET038901
• NIH Device Record Key: dcb2742f-0a79-4ec4-93f0-3bcea7cfd7bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: earflex yellow 25 shore 8x50ml
• Version Model Number: 03890
• Company DUNS: 343947949
• Company Name: DETAX 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
HIBCC	EDET038901 [Primary]

FDA Product Code

• ESD: Hearing Aid, Air-Conduction, Prescription

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: 2023-02-13
• Device Publish Date: 2023-02-03

Devices Manufactured by DETAX GmbH

• EDET045851 - VITA VIONIC® BASE RESIN IMPACT pink 1000g: 2025-06-23
• EDET045861 - VITA VIONIC® BASE RESIN IMPACT pink-translucent 1000g: 2025-06-23
• EDET045871 - VITA VIONIC® TRY-IN RESIN A2 1000g: 2025-06-23
• EDET045901 - VITA VIONIC® DENT RESIN A1 1000g: 2025-06-23
• EDET045911 - VITA VIONIC® DENT RESIN A2 1000g: 2025-06-23
• EDET045921 - VITA VIONIC® DENT RESIN A3 1000g: 2025-06-23
• EDET045931 - VITA VIONIC® DENT RESIN B1 1000g: 2025-06-23
• EDET045941 - VITA VIONIC® DENT RESIN B3 1000g: 2025-06-23