otosil IS-2 A0010200

GUDID EPRCA0010200

IS-2 - 8 double cartridges of 2 x 25 ml ocean-blue / white-opaque

pro3dure medical GmbH

Earmould impression material

• Primary Device ID: EPRCA0010200
• NIH Device Record Key: 96042319-6820-4c07-9f53-567051c02fdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: otosil IS-2
• Version Model Number: 8 double cartridges of 2 x 25 ml
• Catalog Number: A0010200
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EPRCA0010200 [Primary]

FDA Product Code

• LDG: Kit, Earmold, Impression

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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