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Fibrinet®

FDA UDI

Class II (US FDA UDI)

by Vertical Spine, Llc

Identity

Trade Name
FIBRINET® FDA UDI
Generic Name
Haematological concentrate system preparation kit, platelet concentration FDA UDI
Device Name
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. FDA UDI
Model / Reference
510359 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
510359 FDA UDI
Primary DI / UDI-DI
10851802007066 FDA UDI
FDA Product Code
ORG FDA UDI
GMDN Term
Haematological concentrate system preparation kit, platelet concentration FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9245 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 45 Milliliter FDA UDI

Category: Haematological concentrate system preparation kit, platelet concentration

Fibrinet® by Vertical Spine, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haematological concentrate system preparation kit, platelet concentration.

Cleared under the same submission

BK120008 also covers:

BK120009 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vertical Spine, Llc

Sources (1)

  • FDA UDI db21ad8b-3709-4ac5-8d84-d184af88ed9b 38 fields · synced Jun 1, 2026