DEVICE DETAILS
| NAME OF DEVICE | CERVICAL ORTHOSIS |
|---|---|
| ESTABLISHMENT NAME | SOUTHERN CRESCENT SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GMD73262978519A |
| BRAND NAME | OPTEC |
| MEDICAL DEVICE CATEGORY | REUSABLE DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The NEW redesigned PROGLIDE® cervical collar is now better than ever and offers superior immobilization of the cervical region in a comfortable, easy-to-use device that improves patient care. The unique height adjustment technology allows for customized fitting with a simple turn of the knob. With a one-size-fits-all design, the PROGLIDE® reduces inventory stock and saves you money. The PROGLIDE® is a complete solution to individuals with a cervical injury that require the use of an extended wear collar. |
| DEVICE INTENDED PURPOSE | The intended use of PROGLIDE® help support and immobilize the neck after injury, neck strain, or whiplash. The indications for use are as follows: • Cervical Spine precaution for trauma patients • Immobilization for pre and post cervical spine surgery • Degenerative disorders • Spinal Stenosis • Spondylolisthesis • Anterior cervical fusion • Halo removal • Dens type 1 cervical fractures of C2 vertebrate • Anterior discectomy • Teardrop fracture of the vertebral body • Cervical strain • Unstable fracture • Neural Involvement • Atlanto-occipital Dislocation |
| VALIDITY DATE OF REGISTRATION | 28/08/2024 - 27/08/2029 |