FDA.reportPublic FDA data

RegenKit®-THT-4/RegenCell®

Primary DI
07640138980251
Brand
RegenKit®-THT-4/RegenCell®
Company
REGEN LAB SA
Model
RK-THT-4
Published
2019-06-17
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

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640138980251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640138980251076401389802517640138980251

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 Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

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
07640138981616RegenPlasma/RegenKit-Woud Gel-2RK-WG-22023-01-19
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
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

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