SELPHYL® - The SELPHYL® System is designed for the safe and - Factor Medical, Inc.

Duns Number:117697569

Device Description: The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet- 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 36 mL SELPHYL® System is available as a single pack (item number 480910) or as a multipack of 10 each individually packaged kits (item number 480910-10).The 36 mL SELPHYL® System contains 4 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 4 PRFM tubes containing calcium chloride solution with red stoppers, 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.

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More Product Details

Catalog Number

480910

Brand Name

SELPHYL®

Version/Model Number

480910

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 05, 2020

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ORG

Product Code Name

Platelet And Plasma Separator For Bone Graft Handling

Device Record Status

Public Device Record Key

0f13d54b-b1ca-4308-884c-7453a1143ab4

Public Version Date

September 30, 2022

Public Version Number

9

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

30851802007053

Quantity per Package

10

Contains DI Package

10851802007059

Package Discontinue Date

June 05, 2020

Package Status

Not in Commercial Distribution

Package Type

Case

"FACTOR MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6