FIBRINET 510359
GUDID 30850014593033
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 Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration| Primary Device ID | 30850014593033 |
| NIH Device Record Key | 4b642067-37cb-499c-89eb-6e445e017311 |
| 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
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 |
| 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 |
| 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 | 10850014593039 [Primary] |
| GS1 | 10851802007066 [Previous] |
| GS1 | 30850014593033 [Package] Contains: 10850014593039 Package: case [5 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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-07-23 |
| Device Publish Date | 2020-06-05 |
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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