FDA.reportPublic FDA data

World PRP

Primary DI
10754016214124
Brand
World PRP
Company
Luvo Medical Technologies Inc
Model
WORLDPRP
Published
2021-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
BK2105580

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK2105580

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10754016214124PrimaryGS10
00754016214127Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1075401621412410754016214124
00754016214127007540162141277540162141270754016214127

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.

Regulatory Flags#

DUNS number
204046564
Device count
10
Lot or batch
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00754016214004Lucent IPLESM-9200IL2021-06-01
00754016214011Lucent IPL – handpiece3134 A99990012021-06-01
00754016214134Darwin ESK-3272LV2022-10-14
00754016214158Darwin IPL Handpiece3134 A9999001LV2022-10-14
00754016214165Darwin Diode Laser Handpiece9300-A0000101LV2022-10-14
00754016214172RF Microneedling Handpiece3245-A9900201LV2022-10-14
00754016214189Darwin RF Thermal 7600-A992022-10-14
00754016214028Bare 808ESM-9300LD2021-06-02
00754016214035BARE: 808 HANDPIECE 9300-A00001012021-06-02
00754016214127World PRPWORLDPRP2021-08-11
00754016214042Bela MD+ESK-2281HD2021-06-01
00754016214059BELA MD+ AQUA HANDPIECE2225-SHP000032021-06-01
00754016214066BELA MD+ SKIN SCRUBBER HANDPIECEES00762021-06-01
00754016214073BELA MD+ Y HANDPIECE2253-A99002012021-06-01
00754016214080BELA MD+ ELECTROPORATION HANDPIECE2249-A99002012021-06-01
00754016214097BELA MD+ AQUA TIPES25862021-06-01
00754016214103BELA MD+ AQUA TIPES25872021-06-01
00754016214110BELA MD+ DIAMOND TIPES20602021-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08685139210029Centrifuge Container SetEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-04-10
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
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
00850033131215RegenKit®-BCT-T-URegenlab USA LLCORG2026-03-25
08685139210036Exocube SetEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15
08685139210012ExoCubeEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15
08685139210067ExoCube-20PackEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15
08809410200046Dr.PRPRmedica Co.,LtdORG2026-02-02
08809410200053Dr.PRPRmedica Co.,LtdORG2026-02-02
G668FG0010ASCENT FLEXXPRP ORTHOASCENT, LLCORG2026-01-05
G668FG0011ASCENT FLEXXPRP ORTHOASCENT, LLCORG2026-01-05
M713FPRP400RICHPLAT ORTHO 40 PRP SYSTEMFIDIA FARMACEUTICI SPAORG2025-10-31
00850075308095CER-PRP-SINGLE-ARANFAC CORP.ORG2025-10-08
04719875912245Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
04719875912252Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
14719875912242Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
14719875912259Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
00850075308118Cervos Platelet Separator Triple Pack B2RANFAC CORP.ORG2025-07-23
10850075308115Cervos Platelet Separator Triple Pack B2RANFAC CORP.ORG2025-07-23
08435389829089ENDORET KITBIOTECHNOLOGY INSTITUTE SLORG2025-06-03
04719875912122Virtue CPKitAEON BIOTHERAPEUTICS CORP.ORG2025-05-15