Get Info Genosscom Form

The Info Genosscom Form is essential for submitting information regarding medical devices, specifically the GENOSS Collagen Membrane. This guide will help you navigate the online filling process step-by-step to ensure accurate completion.

Follow the steps to successfully complete the form online.

1. Click the ‘Get Form’ button to access the Info Genosscom Form and open it in your preferred online editor.
2. Begin by entering the submitter's information. This includes the company's name, GENOSS Co., Ltd., and its address at IF Gyeonggi R&DB center, 906-5 Iui-dong, Suwon-si, Yeongtong-gu, Gyeonggi-do, 433-270, Korea. Additionally, provide the contact person's name and their phone and fax numbers.
3. In the device name section, fill in the proprietary name, common name, and classification name of the device being reported. For example, enter 'GENOSS Collagen Membrane' as the proprietary name, with 'Resorbable dental barrier membrane, animal source' as the common name.
4. List the predicate devices that relate to the GENOSS Collagen Membrane in the designated area. Mention devices such as RCM6 membrane, Fortgen Oral Membrane, and OSSIX Plus.
5. Provide a detailed description of the GENOSS Collagen Membrane in the description section. Include its purpose, materials used, and any specific functionalities.
6. In the indications for use section, clearly state the different applications for which the membrane is intended, such as guided bone regeneration, ridge augmentation, and treatment of periodontal defects.
7. Fill in the technological characteristics section by listing the materials, type of collagen, and sterilization methods used for the GENOSS Collagen Membrane.
8. Complete the performance data section with the appropriate biocompatibility test results and any relevant in-vitro performancebench testing details to affirm the safety and efficacy of the device.
9. Finalize your entry by reviewing each section for accuracy and completeness before saving changes. You can download, print, or share the filled form as needed.

Complete your document confidently online and ensure successful submission of the Info Genosscom Form.