audioprint INR-1 EPRCA1000283

GUDID EPRCA1000283

audioprint INR-1 Generative resin for production of earpieces

pro3dure medical GmbH

Earmould, custom-made

• Primary Device ID: EPRCA1000283
• NIH Device Record Key: 500c62e6-89a6-4cd2-b9b7-6305e89e8022
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: audioprint INR-1
• Version Model Number: 500 g bottle ; neon-yellow translucent
• Catalog Number: EPRCA1000283
• 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	EPRCA1000283 [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

On-Brand Devices [audioprint INR-1]

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• EPRCA1000287: audioprint INR-1 Generative resin for production of earpieces
• EPRCA1000285: audioprint INR-1 Generative resin for production of earpieces
• EPRCA1000284: audioprint INR-1 Generative resin for production of earpieces
• EPRCA1000283: audioprint INR-1 Generative resin for production of earpieces
• EPRCA1000282: audioprint INR-1 Generative resin for production of earpieces
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• EPRCA1000276: audioprint INR-1 Generative resin for production of earpieces
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• EPRCA1000225: audioprint INR-1 Generative resin for production of earpieces
• EPRCA1000223: audioprint INR-1 Generative resin for production of earpieces
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• EPRCA1000206: audioprint INR-1 Generative resin for production of earpieces
• EPRCA1000205: audioprint INR-1 Generative resin for production of earpieces
• EPRCA1000204: audioprint INR-1 Generative resin for production of earpieces
• EPRCA1000202: audioprint INR-1 Generative resin for production of earpieces
• EPRCA1000292: audioprint INR-1 Generative resin for production of earpieces
• EPRCA1000291: audioprint INR-1 Generative resin for production of earpieces
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• EPRCA1000277: audioprint INR-1 Generative resin for production of earpieces
• EPRCA1000228: audioprint INR-1 Generative resin for production of earpieces
• EPRCA1000227: audioprint INR-1 Generative resin for production of earpieces
• EPRCA1000207: audioprint INR-1 Generative resin for production of earpieces
• EPRCA1000298: audioprint INR-1 Generative resin for production of earpieces
• EPRCA1000295: audioprint INR-1 Generative resin for production of earpieces
• EPRCA1000294: audioprint INR-1 Generative resin for production of earpieces