FDA.reportPublic FDA data

PurePRP Supraphysiologic 60mL GenesisCS Component Concentrating System

Primary DI
00855306003695
Brand
PurePRP Supraphysiologic 60mL GenesisCS Component Concentrating System
Company
EMCYTE CORP.
Model
GS60-SP
Catalog number
GS60-SP
Published
2019-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQCCENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
ORGPlatelet and plasma separator for bone graft handling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1
ORGPlatelet And Plasma Separator For Bone Graft HandlingHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0500550

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0500550

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855306003695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855306003695008553060036958553060036950855306003695

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(239)482-7725support@emcyte.com

Regulatory Flags#

DUNS number
021599728
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855306003688PurePRP Supraphysiologic 30mL GenesisCS Component Concentrating SystemGS30-SPGS30-SP2019-01-08
00855306003701PurePRP Supraphysiologic 120mL GenesisCS Component Concentrating SystemGS120-SPGS120-SP2019-01-08
00855306003008AbsolutePRP 60mL GenesisCS Component Concentrating SystemGS60GS602019-01-08
00855306003015Accelerate Platelet Concentrating System 60mL620-11-02620-11-022019-01-08
00855306003022Accelerate Platelet Concentrating System PRP-S 30mL620-11-07620-11-072019-01-08
00855306003039Accelerate Platelet Concentrating System PRP-S 30mL620-11-06620-11-062019-01-08
00855306003046Accelerate Platelet Concentrating System PRP-S 60mL620-11-08620-11-082019-01-08
00855306003053Concentrating System PRP-S 60mL GenesisCS Component Concentrating System620-11-09620-11-092019-01-08
00855306003084AbsolutePRP 120mL GenesisCS Component Concentrating SystemGS120GS1202019-01-08
00855306003091AbsoluteBMC 120mL GenesisCS Component Concentrating SystemGSBMA-120GSBMA-1202019-01-08
00855306003107AbsoluteBMC 60mL GenesisCS Component Concentrating SystemGSBMA-60GSBMA-602019-01-08
00855306003183PurePRP 60mL GenesisCS Component Concentrating SystemGS60-PUREGS60-PURE2019-01-08
00855306003190AbsolutePRP 30mL GenesisCS Component Concentrating SystemGS30GS302019-01-08
00855306003244Cyclone Bone Marrow Concentration System 60mLCYC-60-01CYC-60-012019-01-08
00855306003251Cyclone Bone Marrow Concentration System 120mLCYC-120-01CYC-120-012019-01-08
00855306003268Accelerate II Bone Marrow Concentrating System 60mL620-32-34620-32-342019-01-08
00855306003275Accelerate II Bone Marrow Concentrating System 120mL620-32-36620-32-362019-01-08
00855306003299Accelerate II Platelet Concentrating System PRP-S 30mL620-22-06620-22-062019-01-08
00855306003305Accelerate II Platelet Concentrating System PRP-S 30mL620-22-07620-22-072019-01-08
00855306003312Accelerate II Platelet Concentrating System PRP-S 60mL620-22-08620-22-082019-01-08

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