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GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and humerus of pediatric patients, who have reached skeletal maturity. The GAP Nail is an intramedullary nail. It is the main component of the GAP Endo-Exo Medullary System. The rest of the components of the system are screws, plates and caps that are assembled to the nail during the surgical procedure. The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP System is used for pediatric patients (child and adolescent) ages 2 to 21. It can be used to correct the following conditions: -Diaphyseal fracture of the femur, tibia and humerus -Fractures of the femoral neck -Subtrochanteric, intertrochanteric and combination fractures -Correction of deformities (OI, Coxa vara, Coxa valga) -Nonunions and malunions
FDA Enforcement
Class II
·Terminated·Pega Medical Inc.·April 8, 2015
ORAgene (Swab-based DNA & Dx Collection Device)
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
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Testosterone Saliva ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Diagnostics Biochem Canada Inc.·1 device
Testosterone ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Diagnostics Biochem Canada Inc.·1 device
Resistin ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Diagnostics Biochem Canada Inc.·1 device
Prolactin (PRL) ELISA
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Diagnostics Biochem Canada Inc.·1 device
Progesterone ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Diagnostics Biochem Canada Inc.·1 device
Progesterone Saliva ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Diagnostics Biochem Canada Inc.·1 device
Free Estriol ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Diagnostics Biochem Canada Inc.·1 device
Anti-Thyroglobulin (Anti-Tg) ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Diagnostics Biochem Canada Inc.·1 device
INSTI HIV-1/HIV-2 ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
iSTATIS COVID-19 Ag HOME TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·1 device
iSTATIS COVID-19 Ag HOME TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·1 device
iSTATIS COVID-19 Ag TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·1 device
INSTI COVID ANTIBODY TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·1 device
INSTI HIV ANTIBODY SELF-TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HIV ANTIBODY SELF-TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HCV ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HCV ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HCV ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device