FIBRINET 510357

GUDID 10850014593015

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.

ROYAL BIOLOGICS INC.

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Primary Device ID10850014593015
NIH Device Record Keyc0566027-536d-4605-903f-f167ad0a8be3
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIBRINET
Version Model NumberPRFMK
Catalog Number510357
Company DUNS080562141
Company NameROYAL BIOLOGICS INC.
Device Count1
DM Exemptfalse
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

Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com
Phone646-642-5853
Emailadam@royalbiologics.com

Device Dimensions

Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter
Total Volume27 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110850014593015 [Primary]
GS110851802007080 [Previous]

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 Number2
Public Version Date2020-07-23
Device Publish Date2020-06-05

On-Brand Devices [FIBRINET]

30850014593033The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous pl
30850014593019The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous pl
10850014593015The FIBRINET® Accessory Kit contains accessories to the FIBRINET® System. The FIBRINET® Syste
00850014593032The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous pl
00850014593025The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous pl
00850014593018The FIBRINET® Accessory Kit contains accessories to the FIBRINET® System. The FIBRINET® Syste

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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