FIBRINET 510357
GUDID 30851802007084
The FIBRINET® Accessory Kit contains accessories to the FIBRINET® System. 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 FIBRINET® Accessory Kit is available as a single pack (item number 510357) or as a multipack of 5 individually packaged kits (item number 510357-5). The FIBRINET® Accessory Kit contains 1 disposable centrifuge carrier with insert and cap and 1 - 50 mL Falcon® tube.
VERTICAL SPINE, LLC
Haematological concentrate system preparation kit, platelet concentration| Primary Device ID | 30851802007084 |
| NIH Device Record Key | 545130b9-67b9-4e85-a0d4-65d8e492417a |
| Commercial Distribution Discontinuation | 2121-06-28 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FIBRINET |
| Version Model Number | 510357 |
| Catalog Number | 510357 |
| Company DUNS | 059517509 |
| Company Name | VERTICAL SPINE, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
Device Dimensions
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10851802007080 [Primary] |
| GS1 | 30851802007084 [Package] Contains: 10851802007080 Package: Case [5 Units] Discontinued: 2121-06-28 In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- BK120008
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 | 2019-07-02 |
| Device Publish Date | 2019-06-24 |
Devices Manufactured by VERTICAL SPINE, LLC
| 30851802007084 - FIBRINET | 2019-07-02The FIBRINET® Accessory Kit contains accessories to the FIBRINET® System. 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 FIBRINET® Accessory Kit is available as a single pack (item number 510357) or as a multipack of 5 individually packaged kits (item number 510357-5). The FIBRINET® Accessory Kit contains 1 disposable centrifuge carrier with insert and cap and 1 - 50 mL Falcon® tube. |
| 30851802007084 - FIBRINET | 2019-07-02 The FIBRINET® Accessory Kit contains accessories to the FIBRINET® System. The FIBRINET® System is designed to be used for the |
| 30851802007060 - FIBRINET® | 2019-06-21 The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a |
| 30851802007077 - FIBRINET® | 2019-06-21 The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a |
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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