PRO3DURE SysTherm PU A4020147

GUDID EPRCA4020147

SysTherm PU Black standard packaging 2x50g

pro3dure medical GmbH

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• Primary Device ID: EPRCA4020147
• NIH Device Record Key: db3640e3-9d7e-415a-9fa0-1b1ad1d5711e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRO3DURE SysTherm PU
• Version Model Number: SysTherm PU Black
• Catalog Number: A4020147
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EPRCA4020147 [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: 2022-12-14
• Device Publish Date: 2022-12-06

On-Brand Devices [PRO3DURE SysTherm PU ]

• EPRCA4020124: SysTherm PU clear-transparent standard packaging 2x50g
• EPRCA4020144: SysTherm PU pink-transparent standard packaging 2x50g
• EPRCA4020143: SysTherm PU Reddish-Transparent standard packaging 2x50g
• EPRCA4020147: SysTherm PU Black standard packaging 2x50g
• EPRCA4020146: SysTherm PU Blue standard packaging 2x50g
• EPRCA4020145: SysTherm PU Red standard packaging 2x50g