Home GUDID 00850033131208 RegenKit®-THT-T-U
Primary DI 00850033131208
Brand RegenKit®-THT-T-U
Company Regenlab USA LLC
Model RK-THT-T-U
Published 2026-03-23
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 Product Codes# Code, Name table Code Name FMF Syringe, Piston FMI Needle, Hypodermic, Single Lumen
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FMF Syringe, Piston General Hospital 2 FMI Needle, Hypodermic, Single Lumen General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850033131208 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850033131208 00850033131208 850033131208 0850033131208
GMDN Terms# Term, Definition table Term Definition Haematological concentrate system preparation kit, platelet concentration A 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 Type Low High Condition Storage Environment Temperature 5 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 087434117 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 09347144013062 Metier Medical METIER MEDICAL LTD FMF 2026-10-19 09347144013123 Metier Medical METIER MEDICAL LTD FMF 2026-10-19 09347144015004 Metier Medical METIER MEDICAL LTD FMF 2026-10-12 09347144016186 Metier Medical METIER MEDICAL LTD FMF 2026-10-12 09347144016216 Metier Medical METIER MEDICAL LTD FMF 2026-10-12 16972857299337 Pen Needles Classic Sandstone Medical (Suzhou) Inc. FMI 2026-10-11 16972857299290 Easydrip Readygard Duo Sandstone Medical (Suzhou) Inc. FMI 2026-10-09 16972857299306 Easydrip Readygard Sandstone Medical (Suzhou) Inc. FMI 2026-10-09 16972857299313 Easydrip Readygard Sandstone Medical (Suzhou) Inc. FMI 2026-10-09 20612479288496 McKesson MCKESSON MEDICAL-SURGICAL INC. FMF 2026-10-08 20612479288526 McKesson MCKESSON MEDICAL-SURGICAL INC. FMF 2026-10-08 00050428167243 TRUEplus TRIVIDIA HEALTH, INC. FMI 2026-10-07 00050428167267 TRUEplus TRIVIDIA HEALTH, INC. FMI 2026-10-07 10304040193843 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193850 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193867 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193874 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193881 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193898 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194109 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194116 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194208 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194215 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194222 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194239 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194246 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194253 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194260 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194277 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194284 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05