FIBRINET® 510359

GUDID 30851802007060

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.

VERTICAL SPINE, LLC

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Primary Device ID30851802007060
NIH Device Record Keydb21ad8b-3709-4ac5-8d84-d184af88ed9b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIBRINET®
Version Model Number510359
Catalog Number510359
Company DUNS059517509
Company NameVERTICAL SPINE, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com

Device Dimensions

Total Volume45 Milliliter
Total Volume45 Milliliter
Total Volume45 Milliliter
Total Volume45 Milliliter
Total Volume45 Milliliter
Total Volume45 Milliliter
Total Volume45 Milliliter
Total Volume45 Milliliter
Total Volume45 Milliliter
Total Volume45 Milliliter
Total Volume45 Milliliter
Total Volume45 Milliliter
Total Volume45 Milliliter
Total Volume45 Milliliter
Total Volume45 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110851802007066 [Primary]
GS130851802007060 [Package]
Contains: 10851802007066
Package: Case [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ORGPlatelet And Plasma Separator For Bone Graft Handling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-06-21
Device Publish Date2016-09-23

Devices Manufactured by VERTICAL SPINE, LLC

30851802007084 - FIBRINET2019-07-02 The FIBRINET® Accessory Kit contains accessories to the FIBRINET® System. The FIBRINET® System is designed to be used for the
30851802007060 - FIBRINET®2019-06-21The 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.
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
FIBRINET
78846899 3306821 Dead/Cancelled
VERTICAL SPINE, LLC
2006-03-27
FIBRINET
FIBRINET
78106996 2851832 Live/Registered
VERTICAL SPINE, LLC
2002-02-05

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