DEVICE: SELPHYL® (10851802007035)
Device Identifier (DI) Information
SELPHYL®
440910
Not in Commercial Distribution
440910
Factor Medical, Inc.
440910
Not in Commercial Distribution
440910
Factor Medical, Inc.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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FDA Product Code
[?]Product Code | Product Code Name |
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ORG | Platelet And Plasma Separator For Bone Graft Handling |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 4 and 35 Degrees Celsius |
Handling Environment Temperature: between 20 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 18 Milliliter |
Device Record Status
77a0b4c9-0f81-4e86-ae9d-b6cbbe985a8c
September 30, 2022
9
September 23, 2016
September 30, 2022
9
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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30851802007039 | 10 | 10851802007035 | 2020-06-05 | Not in Commercial Distribution | case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
6103171670
jfaust@ubsaesthetics.com
jfaust@ubsaesthetics.com