audioprint INR-1 A1000281

GUDID EPRCA1000281

audioprint INR-1 Generative resin for production of earpieces

pro3dure medical GmbH

Earmould, custom-made

• Primary Device ID: EPRCA1000281
• NIH Device Record Key: bf65dec9-5951-4d76-9bef-eb0234fbe13b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: audioprint INR-1
• Version Model Number: 500 g bottle ; neon-green translucent
• Catalog Number: A1000281
• Company DUNS: 312947842
• Company Name: pro3dure medical 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: true
• Expiration Date: true
• 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
HIBCC	EPRCA1000281 [Primary]

FDA Product Code

• ESD: Hearing Aid, Air Conduction

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: 2022-09-20
• Device Publish Date: 2022-09-12

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