SELPHYL®

Primary DI
30851802007046
Brand
SELPHYL®
Company
FACTOR MEDICAL, LLC
Model
450910
Catalog number
450910
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 450910) or as a multipack of 10 each individually packaged kits (item number 450910-10). 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, a 20 mL PRFM vialwith closure containing calcium chloride solution, 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
2016-09-23
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
BK1200080

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1200080

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30851802007046PackageGS110In Commercial Distribution
10851802007042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085180200704630851802007046
1085180200704210851802007042

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system preparation kit, platelet concentrationA collection of sterile 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 typically includes a blood withdrawal set, tubes, and syringes. 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. The glue-like product is applied to the surface of the injured tissue or bone where its adherent properties form a haemostatic barrier and enhance regeneration. 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 Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6103171670jfaust@ubsaesthetics.com

Regulatory Flags#

DUNS number
080384012
Device count
1
DM exempt
true
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
30851802007107SELPHYL®PRFM4409102020-06-05
30851802007008SELPHYL®4209104209102016-09-23
30851802007022SELPHYL® 4309104309102016-09-23
30851802007053SELPHYL®4809104809102016-09-23

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