audioprint L-2 FLX A4020229

GUDID EPRCA4020229

audioprint L-2 I FLX 100 g; clear transparent

pro3dure medical GmbH

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• Primary Device ID: EPRCA4020229
• NIH Device Record Key: 46309872-2178-4891-ae49-80658ab3ffe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: audioprint L-2 FLX
• Version Model Number: 100 g - Clear Transparent
• Catalog Number: A4020229
• 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
• 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	EPRCA4020229 [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: 2023-10-26
• Device Publish Date: 2023-10-18

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• EPRCA0034151 - otosil SL-1: 2023-10-26 otosil SL-1 100 g; clear transparent
• EPRCA0034160 - otosil SL-1 I MSI: 2023-10-26 otosil SL-1 I MSI 250 g; clear transparent
• EPRCA0034300 - otosil protect 50 I MSI: 2023-10-26 otosil protect 50 I MSI 8 double-cartridges with 2x24 ml each
• EPRCA0034301 - otosil protect 50 I MSI: 2023-10-26 otosil protect 50 I MSI 8 double-cartridges with 2x24 ml each
• EPRCA0034302 - otosil protect 50 I MSI: 2023-10-26 otosil protect 50 I MSI 8 double-cartridges with 2x24 ml each