FIBRINET 510359
GUDID 00850014593032
The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The 45 mL FIBRINET® System is available as a single pack (item number 510359) or as a multipack of 5 individually packaged kits (item number 510359-5). The 45 mL FIBRINET® System contains 5 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 1 PRFM tube containing calcium chloride solution with red stopper, two 30 mL membrane vials with closure containing calcium chloride solution, 1 latex free disposable tourniquet, 2 BD Vacutainer® Luer-Lok™ access devices, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, 2 BD Vacutainer® Blood transfer devices, and 1 vial adapter.
ROYAL BIOLOGICS INC.
Haematological concentrate system preparation kit, platelet concentration| Primary Device ID | 00850014593032 |
| NIH Device Record Key | bdcd57c4-6b9f-444a-a7a1-ac2766e21257 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FIBRINET |
| Version Model Number | PFRMK |
| Catalog Number | 510359 |
| Company DUNS | 080562141 |
| Company Name | ROYAL BIOLOGICS INC. |
| 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 | 646-642-5853 |
| adam@royalbiologics.com | |
| Phone | 646-642-5853 |
| adam@royalbiologics.com | |
| Phone | 646-642-5853 |
| adam@royalbiologics.com | |
| Phone | 646-642-5853 |
| adam@royalbiologics.com | |
| Phone | 646-642-5853 |
| adam@royalbiologics.com | |
| Phone | 646-642-5853 |
| adam@royalbiologics.com | |
| Phone | 646-642-5853 |
| adam@royalbiologics.com | |
| Phone | 646-642-5853 |
| adam@royalbiologics.com | |
| Phone | 646-642-5853 |
| adam@royalbiologics.com | |
| Phone | 646-642-5853 |
| adam@royalbiologics.com | |
| Phone | 646-642-5853 |
| adam@royalbiologics.com | |
| Phone | 646-642-5853 |
| adam@royalbiologics.com | |
| Phone | 646-642-5853 |
| adam@royalbiologics.com | |
| Phone | 646-642-5853 |
| adam@royalbiologics.com | |
| Phone | 646-642-5853 |
| adam@royalbiologics.com | |
| Phone | 646-642-5853 |
| adam@royalbiologics.com | |
| Phone | 646-642-5853 |
| adam@royalbiologics.com |
Device Dimensions
| Total Volume | 45 Milliliter |
| Total Volume | 45 Milliliter |
| Total Volume | 45 Milliliter |
| Total Volume | 45 Milliliter |
| Total Volume | 45 Milliliter |
| Total Volume | 45 Milliliter |
| Total Volume | 45 Milliliter |
| Total Volume | 45 Milliliter |
| Total Volume | 45 Milliliter |
| Total Volume | 45 Milliliter |
| Total Volume | 45 Milliliter |
| Total Volume | 45 Milliliter |
| Total Volume | 45 Milliliter |
| Total Volume | 45 Milliliter |
| Total Volume | 45 Milliliter |
| Total Volume | 45 Milliliter |
| Total Volume | 45 Milliliter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850014593032 [Primary] |
| GS1 | 10850014593039 [Previous] |
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 | 2023-02-20 |
| Device Publish Date | 2023-02-10 |
On-Brand Devices [FIBRINET]
| 30850014593033 | The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous pl |
| 30850014593019 | The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous pl |
| 10850014593015 | The FIBRINET® Accessory Kit contains accessories to the FIBRINET® System. The FIBRINET® Syste |
| 00850014593032 | The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous pl |
| 00850014593025 | The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous pl |
| 00850014593018 | The FIBRINET® Accessory Kit contains accessories to the FIBRINET® System. The FIBRINET® Syste |
Trademark Results [FIBRINET]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIBRINET 78846899 3306821 Dead/Cancelled |
VERTICAL SPINE, LLC 2006-03-27 |
 FIBRINET 78106996 2851832 Live/Registered |
VERTICAL SPINE, LLC 2002-02-05 |
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