FDA.reportPublic FDA data

Cyclone Bone Marrow Concentration System 60mL

Primary DI
00855306003244
Brand
Cyclone Bone Marrow Concentration System 60mL
Company
EMCYTE CORP.
Model
CYC-60-01
Catalog number
CYC-60-01
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070666000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070666000GENESISCS COMPONENT CONCENTRATING SYSTEMPerfusion Partners & Assoc., Inc.2007-06-20JQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855306003244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855306003244008553060032448553060032440855306003244

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
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
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
10850044310224Thermo ScientificThermo Electron LED GmbHJQC2026-04-02
10850044310248Thermo ScientificThermo Electron LED GmbHJQC2026-04-02
00860015460660Nextgen CentrifugeT AESTHETICS LLCJQC2026-04-02
00810052863016DASH Flex 24 Centrifuge, Royal BiologicsDRUCKER DIAGNOSTICSJQC2026-03-25
00810052864969DASH Flex 24 Centrifuge, Royal BiologicsDRUCKER DIAGNOSTICSJQC2026-03-25
00840095681674Globe ScientificGLOBE SCIENTIFIC INC.JQC2026-03-16
10850044310255Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310286Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310293Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310378Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310392Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310484Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310491Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
00664816006030LW Scientific, Inc`LW SCIENTIFIC, INC.JQC2026-03-02
00664816006016LW ScientificLW SCIENTIFIC, INC.JQC2026-02-20
00664816005682LW Scientific, Inc.LW SCIENTIFIC, INC.JQC2026-02-16
00810052864945642M Centrifuge, AccuReferenceDRUCKER DIAGNOSTICSJQC2026-02-02
00810052864938TrueBond Set 3 Centrifuge, ZoetisDRUCKER DIAGNOSTICSJQC2026-01-15