SELPHYL® 420910

GUDID 30851802007008

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 9 mL SELPHYL® System is available as a single pack (item number 420910) or as a multipack of 10 individually packaged kits (item number 420910-10). The 9 mL SELPHYL® System contains 1 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, 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 Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration
Primary Device ID30851802007008
NIH Device Record Keyf6f54484-e23b-4e18-b02d-31eb95dccf93
Commercial Distribution StatusIn Commercial Distribution
Brand NameSELPHYL®
Version Model Number420910
Catalog Number420910
Company DUNS080384012
Company NameFACTOR MEDICAL, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com
Phone6103171670
Emailjfaust@ubsaesthetics.com

Device Dimensions

Total Volume9 Milliliter
Total Volume9 Milliliter
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Operating and Storage Conditions

Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110851802007004 [Primary]
GS130851802007008 [Package]
Contains: 10851802007004
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ORGPlatelet And Plasma Separator For Bone Graft Handling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-03-13
Device Publish Date2016-09-23

On-Brand Devices [SELPHYL®]

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

Trademark Results [SELPHYL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SELPHYL
SELPHYL
98373754 not registered Live/Pending
VIAS Partners
2024-01-24
SELPHYL
SELPHYL
77629119 3764831 Live/Registered
FACTORS MEDICAL LLC
2008-12-09

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