RegenPlasma/RegenKit-Woud Gel-2

Primary DI
07640138981616
Brand
RegenPlasma/RegenKit-Woud Gel-2
Company
REGEN LAB SA
Model
RK-WG-2
Device description
The RegenKit®-Wound Gel-2 contains 2 RegenWound PRP Tubes and 1 RegenWound ATS Tube. INTENDED USE / INDICATIONS FOR USERegenKit®-Wound Gel-2 is designed to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel (RegenWound Gel) from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the RegenWound Gel is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers and diabetic ulcers, and mechanically or surgically debrided wounds.
Published
2023-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640138981616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640138981616076401389816167640138981616

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
482206518
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
07640138980794RegenKit®-THT-48495-9-0042016-09-15
07640138981784A-CP-Kit-3 (8ml)A-CP-3-8ml2023-01-20
07640138981012RegenETR-ET-3x202022-06-28
07640138981630RegenKit-BCT-3 (20ml)/RegenPlasmaRK-BCT-3-202022-04-02
07640138981593RegenKit-THT-3/RegenCell®RK-THT-3-202021-10-26
07640138981487RegenETR-ET-3 x 102020-11-19
07640138981449Accessory Set BCA-SET3-202020-11-05
07640138980329Accessory Set BCA-SET32020-10-13
07640138981432Accessory Set BCA-SET3-U2020-10-05
07640138981364RegenETR-ET-32020-02-24
07640138980244RegenKit®-THT-1/RegenCell®RK-THT-12019-06-17
07640138980251RegenKit®-THT-4/RegenCell®RK-THT-42019-06-17
07640138980565RegenKit®-THT-2/RegenCell®RK-THT-22019-06-17
07640138980039RegenKit®-BCT-2 PlusRK-BCT-2A2016-09-15
07640138980138RegenKit®-BCT-1 PlusRK-BCT-1A2016-09-15
07640138980190A-CP-Kit-1A-CP-12016-09-15
07640138980220Regen Spray ApplicatorR-A/NAC12016-09-15
07640138980268RegenKit®-BCT-1RK-BCT-12016-09-15
07640138980275RegenKit®-BCT-2RK-BCT-22016-09-15
07640138980282RegenKit®-BCT-4RK-BCT-42016-09-15

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
057141883018083CP™ CounterbalanceReapplix ApSPMQ2019-05-23
057141883080053CP™ Centrifuge KitReapplix ApSPMQ2019-05-23
057141885010003C Patch® Needle HolderReapplix ApSPMQ2019-05-23