PRO3DURE GR-10 A1000814

GUDID EPRCA1000814

audioprint GR-10

pro3dure medical GmbH

Earmould, custom-made

• Primary Device ID: EPRCA1000814
• NIH Device Record Key: 3cf146b4-74f0-4169-850e-994278754a27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRO3DURE GR-10
• Version Model Number: 1kg - blue grotto transparent
• Catalog Number: A1000814
• 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

Customer Support Contacts

• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EPRCA1000814 [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: 2022-10-28
• Device Publish Date: 2022-10-20

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• EPRCA1000811: audioprint GR-10
• EPRCA1000804: audioprint GR-10
• EPRCA1000803: audioprint GR-10
• EPRCA1000802: audioprint GR-10
• EPRCA1000800: audioprint GR-10
• EPRCA1000982: audioprint GR-10
• EPRCA1000885: audioprint GR-10
• EPRCA1000884: audioprint GR-10
• EPRCA1000883: audioprint GR-10
• EPRCA1000881: audioprint GR-10
• EPRCA1000838: audioprint GR-10
• EPRCA1000833: audioprint GR-10
• EPRCA1000832: audioprint GR-10
• EPRCA1000831: audioprint GR-10
• EPRCA1000827: audioprint GR-10
• EPRCA1000826: audioprint GR-10
• EPRCA1000825: audioprint GR-10
• EPRCA1000816: audioprint GR-10
• EPRCA1000815: audioprint GR-10
• EPRCA1000814: audioprint GR-10
• EPRCA1000813: audioprint GR-10
• EPRCA1000808: audioprint GR-10
• EPRCA1000806: audioprint GR-10
• EPRCA1000805: audioprint GR-10