FDA.reportPublic FDA data

Box - 3C Patch® Kit

Primary DI
05714188505503
Brand
Box - 3C Patch® Kit
Company
Reapplix ApS
Model
2
Device description
This is the outer label for the box that includes 12 3C Patch® Kits and the IFU.
Published
2019-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PMQPeripheral Blood Processing Device For Wound Management

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMQPeripheral Blood Processing Device For Wound ManagementHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1402110
BK2004710

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1402110
BK2004710

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714188505503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714188505503057141885055035714188505503

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4588168066info@reapplix.com

Regulatory Flags#

DUNS number
312293991
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
057141883018083CP™ Counterbalance22019-05-23
057141883080053CP™ Centrifuge Kit22019-05-23
057141885010003C Patch® Needle Holder22019-05-23
057141885021063C Patch® Device22019-05-23
057141885050083C Patch® Kit22019-05-23
057141885052064 x (21G Needle + 3C Patch® Needle Holder)22019-05-23
057141885056023C Patch® Device - Extra Component Set22019-05-23
057141880215773CP™ Centrifuge12018-07-19
057141883080673CP™ Centrifuge Kit12019-04-03
057141883018223CP™ Counterbalance12018-07-19
057141883080503CP™ Centrifuge Kit12018-07-19
057141885010933C Patch® Needle Holder12018-07-19
057141885021513C Patch® Device12018-07-19
057141885050463C Patch® Kit12018-07-19
05714188505220Venipuncture Needle and 3C Patch® Needle Holder - Extra Component Set12019-01-09
057141885055413C Patch® Kit - Box12018-07-19
057141885056193C Patch® Device - Extra Component Set12019-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850033131192Cellular MembraneRegenlab USA LLCPMQ2025-12-04
00850033131178RegenKit-ATS-T-URegenlab USA LLCPMQ2025-10-31
00850033131185RegenKit-ATS-3-URegenlab USA LLCPMQ2025-10-31
00850047730305Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00850047730312Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00850047730329Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00850047730336Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00850047730343Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00852714003279CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003286CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003293CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003309CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003323CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003330CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003347CentrioNuo Therapeutics, Inc.PMQ2025-09-01
10860000244319ActiGraftREDDRESS LTDPMQ2025-03-23
00860000244312ActiGraftREDDRESS LTDPMQ2025-03-23
008527140032484TRNuo Therapeutics, Inc.PMQ2024-03-21
00850033131093RegenKit Wound-GelRegenlab USA LLCPMQ2024-03-12
00850047730008Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730015Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730022Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730039Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730046Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730053Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730060Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730077Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
07640138981616RegenPlasma/RegenKit-Woud Gel-2REGEN LAB SAPMQ2023-01-19
057141883018083CP™ CounterbalanceReapplix ApSPMQ2019-05-23
057141883080053CP™ Centrifuge KitReapplix ApSPMQ2019-05-23