otosil PS-1 A0011000

GUDID EPRCA0011000

otosil PS-1 2 x 300g ; Orange - White

pro3dure medical GmbH

Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material

• Primary Device ID: EPRCA0011000
• NIH Device Record Key: dbda7a49-bda7-4973-a084-1951a37292ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: otosil PS-1
• Version Model Number: 2 x 300g ; Orange - White
• Catalog Number: A0011000
• 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	EPRCA0011000 [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

Devices Manufactured by pro3dure medical GmbH

• EPRCA0010200 - otosil IS-2: 2023-10-26 IS-2 - 8 double cartridges of 2 x 25 ml ocean-blue / white-opaque
• EPRCA0011000 - otosil PS-1: 2023-10-26otosil PS-1 2 x 300g ; Orange - White
• EPRCA0011000 - otosil PS-1: 2023-10-26 otosil PS-1 2 x 300g ; Orange - White
• EPRCA0034150 - otosil SL-1: 2023-10-26 otosil SL-1 250 g; clear transparent
• 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