luxaprint 3D shell UV white 1000 g

GUDID EDET038411

DETAX GmbH & Co. KG

Earmould, custom-made

• Primary Device ID: EDET038411
• NIH Device Record Key: 54a9d6dd-24c8-434d-a990-a7db82f734a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: luxaprint 3D shell UV white 1000 g
• Version Model Number: 03841
• Company DUNS: 317099257
• Company Name: DETAX GmbH & Co. KG
• 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: 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	EDET038411 [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: 2022-11-02
• Device Publish Date: 2022-10-25

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• EDET042381 - detax softwear 2.0 blue 60 shore 2 x 50 ml: 2022-11-03
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