FIBRINET® 510358

GUDID 30851802007077

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.

VERTICAL SPINE, LLC

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: 30851802007077
• NIH Device Record Key: 55905992-b0b3-4f16-be4d-b17132ba3ae2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIBRINET®
• Version Model Number: 510358
• Catalog Number: 510358
• Company DUNS: 059517509
• Company Name: VERTICAL SPINE, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6103171670
• Email: jfaust@ubsaesthetics.com
• Phone: 6103171670
• Email: jfaust@ubsaesthetics.com
• Phone: 6103171670
• Email: jfaust@ubsaesthetics.com
• Phone: 6103171670
• Email: jfaust@ubsaesthetics.com
• Phone: 6103171670
• Email: jfaust@ubsaesthetics.com
• Phone: 6103171670
• Email: jfaust@ubsaesthetics.com
• Phone: 6103171670
• Email: jfaust@ubsaesthetics.com
• Phone: 6103171670
• Email: jfaust@ubsaesthetics.com
• Phone: 6103171670
• Email: jfaust@ubsaesthetics.com
• Phone: 6103171670
• Email: jfaust@ubsaesthetics.com
• Phone: 6103171670
• Email: jfaust@ubsaesthetics.com
• Phone: 6103171670
• Email: jfaust@ubsaesthetics.com
• Phone: 6103171670
• Email: jfaust@ubsaesthetics.com
• Phone: 6103171670
• Email: jfaust@ubsaesthetics.com
• Phone: 6103171670
• Email: jfaust@ubsaesthetics.com

Device Dimensions

• Total Volume: 27 Milliliter
• Total Volume: 27 Milliliter
• Total Volume: 27 Milliliter
• Total Volume: 27 Milliliter
• Total Volume: 27 Milliliter
• Total Volume: 27 Milliliter
• Total Volume: 27 Milliliter
• Total Volume: 27 Milliliter
• Total Volume: 27 Milliliter
• Total Volume: 27 Milliliter
• Total Volume: 27 Milliliter
• Total Volume: 27 Milliliter
• Total Volume: 27 Milliliter
• Total Volume: 27 Milliliter
• Total Volume: 27 Milliliter

Operating and Storage Conditions

• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10851802007073 [Primary]
GS1	30851802007077 [Package]; Contains: 10851802007073; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK120008

FDA Product Code

• ORG: Platelet And Plasma Separator For Bone Graft Handling

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-06-21
• Device Publish Date: 2016-09-23

Devices Manufactured by VERTICAL SPINE, LLC

• 30851802007084 - FIBRINET: 2019-07-02 The FIBRINET® Accessory Kit contains accessories to the FIBRINET® System. The FIBRINET® System is designed to be used for the
• 30851802007060 - FIBRINET®: 2019-06-21 The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a
• 30851802007077 - FIBRINET®: 2019-06-21The 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.
• 30851802007077 - FIBRINET®: 2019-06-21 The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a