SELPHYL®

Primary DI
30851802007107
Brand
SELPHYL®
Company
FACTOR MEDICAL, LLC
Model
PRFM
Catalog number
440910
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.
Published
2020-06-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ORGPlatelet And Plasma Separator For Bone Graft Handling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORGPlatelet And Plasma Separator For Bone Graft HandlingHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1700960

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1700960

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30851802007107PackageGS110In Commercial Distribution
10851802007035PreviousGS10
10851802007103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085180200710730851802007107
1085180200703510851802007035
1085180200710310851802007103

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system preparation kit, platelet concentrationA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume18Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature20 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6103171670jfaust@ubsmed.com

Regulatory Flags#

DUNS number
080384012
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30851802007091SELPHYL®PRFM4209102020-06-05
30851802007008SELPHYL®4209104209102016-09-23
30851802007022SELPHYL® 4309104309102016-09-23
30851802007046SELPHYL®4509104509102016-09-23
30851802007053SELPHYL®4809104809102016-09-23

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