FDA.reportPublic FDA data

PurePRP Supraphysiologic 30mL GenesisCS Component Concentrating System

Primary DI
00855306003688
Brand
PurePRP Supraphysiologic 30mL GenesisCS Component Concentrating System
Company
EMCYTE CORP.
Model
GS30-SP
Catalog number
GS30-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
00855306003688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855306003688008553060036888553060036880855306003688

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system preparation kit, bone marrow concentrationA collection of sterile devices typically used at the point-of-care for the rapid preparation of autologous bone marrow aspirate concentrate (BMAC) from bone marrow aspirate. The kit components, with the bone marrow aspirate, are directly placed in a dedicated centrifuge that separates and concentrates the bone marrow. The cellular BMAC preparations are typically applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process. The kit may include specimen drawing devices. 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
00855306003695PurePRP Supraphysiologic 60mL GenesisCS Component Concentrating SystemGS60-SPGS60-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874104928Life PRP LLCLife PRP, LLCJQC2026-05-30
10850044310262Thermo ScientificThermo Electron LED GmbHJQC2026-05-21
10850044310279Thermo ScientificThermo Electron LED GmbHJQC2026-05-21
10850044310309Thermo ScientificThermo Electron LED GmbHJQC2026-05-21
00810052864990Boost 2 Flex DC Centrifuge, RevanceDRUCKER DIAGNOSTICSJQC2026-05-11
00810052865003Boost 4 Centrifuge, Pointiva MedicalDRUCKER DIAGNOSTICSJQC2026-05-11
00810052864983DASH Pro 24 Centrifuge, DruckerDRUCKER DIAGNOSTICSJQC2026-05-04
00810052864976TrueBond TriFLEX Centrifuge, PivetalDRUCKER DIAGNOSTICSJQC2026-04-29
10850044310323Fisher ScientificThermo Electron LED GmbHJQC2026-04-22
10850044310347Fisher ScientificThermo Electron LED GmbHJQC2026-04-22
10850044310354Fisher ScientificThermo Electron LED GmbHJQC2026-04-22
10850044310422Fisher ScientificThermo Electron LED GmbHJQC2026-04-22
00850083564001MARGENIXBahia Medical Inc.ORG2026-04-03
00850083564025MARGENIXBahia Medical Inc.ORG2026-04-03
00850083564049GoldrushBahia Medical Inc.ORG2026-04-03
00850083564056GoldrushBahia Medical Inc.ORG2026-04-03
00850083564063GenesisBahia Medical Inc.ORG2026-04-03
10850044310224Thermo ScientificThermo Electron LED GmbHJQC2026-04-02
10850044310248Thermo ScientificThermo Electron LED GmbHJQC2026-04-02
00860015460660Nextgen CentrifugeT AESTHETICS LLCJQC2026-04-02
00850023741561CERVOS PLATELET SEPARATOR 80 KITRANFAC CORP.ORG2026-03-30
00850075308088CER-PRP-160 STERILITY PACKRANFAC CORP.ORG2026-03-30
00850075308101CER-PRP-160 KitRANFAC CORP.ORG2026-03-30
00850075308163CER-PRP-40 KIT F/G, STERILERANFAC CORP.ORG2026-03-30
B708XCPC120XCELLAPEX BIOLOGIX , LLCORG2026-03-26
B708XCPC60XCELLAPEX BIOLOGIX , LLCORG2026-03-26
00810052863016DASH Flex 24 Centrifuge, Royal BiologicsDRUCKER DIAGNOSTICSJQC2026-03-25
00810052864969DASH Flex 24 Centrifuge, Royal BiologicsDRUCKER DIAGNOSTICSJQC2026-03-25
00850033131215RegenKit®-BCT-T-URegenlab USA LLCORG2026-03-25
08685139210036Exocube SetEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15