AccessGUDID - DEVICE: SELPHYL® (10851802007035)

GUDID

Device Identifier (DI) Information

Brand Name: SELPHYL®
Version or Model: 440910
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 440910
Company Name: Factor Medical, Inc.

Primary DI Number: 10851802007035
Issuing Agency: GS1
Commercial Distribution End Date: June 05, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 117697569 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ORG	Platelet And Plasma Separator For Bone Graft Handling

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 18 Milliliter

Device Record Status

Public Device Record Key: 77a0b4c9-0f81-4e86-ae9d-b6cbbe985a8c
Public Version Date: September 30, 2022
Public Version Number: 9
DI Record Publish Date: September 23, 2016