RICHPLAT ORTHO PRP SYSTEM FPRP20

GUDID M713FPRP200

The RICHPLAT ORTHO™ Platelet Rich Plasma System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.

FIDIA FARMACEUTICI SPA

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• Primary Device ID: M713FPRP200
• NIH Device Record Key: 5baa326c-355a-42e0-866b-0753d2a088f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RICHPLAT ORTHO PRP SYSTEM
• Version Model Number: FPRP20
• Catalog Number: FPRP20
• Company DUNS: 428453013
• Company Name: FIDIA FARMACEUTICI SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M713FPRP200 [Primary]
HIBCC	M713FPRP201 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• ORG: Platelet And Plasma Separator For Bone Graft Handling

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-02
• Device Publish Date: 2021-03-25

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