FIBRINET

Primary DI
30850014593033
Brand
FIBRINET
Company
ROYAL BIOLOGICS INC.
Model
PFRMK
Catalog number
510359
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 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.
Published
2020-06-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
30850014593033PackageGS15In Commercial Distribution
10851802007066PreviousGS10
10850014593039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085001459303330850014593033
1085180200706610851802007066
1085001459303910850014593039

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 Volume45Milliliter

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014593629BioIncyte5103565103562023-02-10
00850014593636SeriVium5103555103552023-02-10
00850014593643AlVeo5103545103542023-02-10
00850014593018FIBRINETPRFMK5103572023-02-10
00850014593025FIBRINETPRFMK5103582023-02-10
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

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