FDA.reportPublic FDA data

FIBRINET

Primary DI
00850014593025
Brand
FIBRINET
Company
ROYAL BIOLOGICS INC.
Model
PRFMK
Catalog number
510358
Device description
"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 27 mL FIBRINET® System is available as a single pack (item number 510358) or as a multipack of 5 individually packaged kits (item number 510358-5). The 27 mL FIBRINET® System contains 3 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, one 30 mL membrane vial 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."
Published
2023-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ORGPlatelet And Plasma Separator For Bone Graft Handling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORGPlatelet And Plasma Separator For Bone Graft HandlingHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850014593022PreviousGS10
00850014593025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001459302210850014593022
00850014593025008500145930258500145930250850014593025

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system preparation kit, platelet concentrationA collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume27Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature20 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
646-642-5853adam@royalbiologics.com

Regulatory Flags#

DUNS number
080562141
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014593629BioIncyte5103565103562023-02-10
00850014593636SeriVium5103555103552023-02-10
00850014593643AlVeo5103545103542023-02-10
00850014593018FIBRINETPRFMK5103572023-02-10
00850014593032FIBRINETPFRMK5103592023-02-10
10850014593626BioIncyte5103565103562023-02-10
10850014593633SeriVium5103555103552023-02-10
10850014593640AlVeo5103545103542023-02-10
00850014593650Bio-Reign 3DBR-G5BR-G52023-02-10
00850014593667Bio-Reign 3DBR-G10BR-G102023-02-10
00850014593674Bio-Reign 3DBR-G20BR-G202023-02-10
00850014593681Bio-Reign 3DBR-G30BR-G302023-02-10
00850014593698Bio-Reign 3DBR-s25x25x3BR-s25x25x32023-02-10
00850014593704Bio-Reign 3DBR-s25x50x3BR-s25x50x32023-02-10
00850014593711Bio-Reign 3DBR-s25x75x3BR-s25x75x32023-02-10
00850014593728Bio-Reign 3DBR-s25x125x3BR-s25x125x32023-02-10
00850014593735Bio-Reign 3DBR-s25x25x5BR-s25x25x52023-02-10
00850014593742Bio-Reign 3DBR-s25x50x5BR-s25x50x52023-02-10
00850014593759Bio-Reign 3DBR-s25x75x5BR-s25x75x52023-02-10
00850014593766Bio-Reign 3DBR-s25x125x5BR-s25x125x52023-02-10

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