SELPHYL® 440910

GUDID 30851802007107

The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. SELPHYL ® removes contaminating red blood cells and white blood cells. PRP is converted to Platelet-rich Fibrin Matrix (PRFM) through a controlled process, creating a scaffold that serves to protect and preserve platelets. The 18 mL SELPHYL® System is available as a single pack (item number 440910) or as a multipack of 10 each individually packaged kits (item number 440910-10). The 18 mL SELPHYL® System contains 2 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 2 PRFM tubes containing calcium chloride solution with red stopper, 1 latex free disposable tourniquet, 1 BD Vacutainer® Luer-Lok™ access device, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, and 1 BD Vacutainer® Blood transfer device.

FACTOR MEDICAL, LLC

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: 30851802007107
• NIH Device Record Key: e9134f6d-77f2-4648-ab4e-4ce042b9bd3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SELPHYL®
• Version Model Number: PRFM
• Catalog Number: 440910
• Company DUNS: 080384012
• Company Name: FACTOR MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• 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@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com
• Phone: 6103171670
• Email: jfaust@ubsmed.com

Device Dimensions

• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter
• Total Volume: 18 Milliliter

Operating and Storage Conditions

• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10851802007035 [Previous]
GS1	10851802007103 [Primary]
GS1	30851802007107 [Package]; Contains: 10851802007103; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK170096

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: 2
• Public Version Date: 2020-07-23
• Device Publish Date: 2020-06-05

On-Brand Devices [SELPHYL®]

• 30851802007053: The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-rich-
• 30851802007046: The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-rich-
• 10851802007035: The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-rich-
• 30851802007022: The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-rich-
• 30851802007008: The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-rich-
• 30851802007107: The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-rich-
• 30851802007091: The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-rich-