FIBRINET

Basic Information

• Brand Name: FIBRINET
• Primary DI: 10851802007080
• Version / Model: 510357
• Catalog Number: 510357
• Company Name: VERTICAL SPINE, LLC
• Labeler DUNS: 059517509
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-24
• Public Version: 2
• Public Version Date: 2020-07-23
• Public Version Status: Update
• Public Device Record Key: 545130b9-67b9-4e85-a0d4-65d8e492417a
• Distribution End Date: 2121-06-28

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	864.9245	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46923	Haematological concentrate system preparation kit, platelet concentration	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30851802007084	GS1	Case	5	In Commercial Distribution	2121-06-28
Primary	10851802007080	GS1

Premarket Submissions

Submission Number	Supplement Number
BK120008	0
BK120009	0

Device Sizes

Type	Value	Unit	Text
Total Volume	50	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 35 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius