OIS - BEUDAMED

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

Limbus AI Inc.

Manufacturer

🇨🇦 Canada·Kiwa Dare B.V.

Limbus AI Inc.

Manufacturer

🇨🇦 Canada·2 Basic UDI-DIs·3 Devices

LIMBUS AI

FDA registration

LIMBUS AI·2 products·🇨🇦 Canada

ORAQ AI INC.

FDA registration

ORAQ AI INC.·1 product·🇨🇦 Canada

PERIMETER MEDICAL IMAGING AI, INC.

FDA registration

PERIMETER MEDICAL IMAGING AI, INC.·2 products·🇨🇦 Canada

INSTRUMENTS FOR RADIOTHERAPY SIMULATION - SOFTWARE ACCESSORIES

Device

EU MDR · Eu Md Class 2b ·Limbus AI Inc.·On the market·14 countries

Limbus Contour

Device

EU MDD · Eu Md Class 1 ·Limbus AI Inc.·No longer on the market·13 countries

INSTRUMENTS FOR RADIOTHERAPY SIMULATION - SOFTWARE ACCESSORIES

Device

EU MDR · Eu Md Class 2b ·Limbus AI Inc.·On the market·14 countries

Prollenium Medical Technologies Inc.

Manufacturer

🇨🇦 Canada·32 Basic UDI-DIs·32 Devices·1 Importer·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, and NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY

Delfi Medical Innovations Inc.

Manufacturer

🇨🇦 Canada·20 Basic UDI-DIs·30 Devices·2 Importers·National Standards Authority of Ireland (NSAI)

Limbus Contour

Basic UDI-DI

EU MDD · Eu Md Class 1 ·Limbus AI Inc.·1 device

Limbus Contour

Basic UDI-DI

EU MDR · Eu Md Class 2b ·Limbus AI Inc.·2 devices