printodent GR-19.1 OA D1001501

GUDID EPRCD1001501

pro3dure medical GmbH

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• Primary Device ID: EPRCD1001501
• NIH Device Record Key: d31c2950-af28-4f24-835a-f75390007ad1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: printodent GR-19.1 OA
• Version Model Number: clear-transparent, 1000g
• Catalog Number: D1001501
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EPRCD1001501 [Primary]

FDA Product Code

• DYT: Maintainer, Space Preformed, Orthodontic

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: 2023-09-06
• Device Publish Date: 2023-08-29

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: 2023-10-26 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