This facility is provided to enable any interested parties to search for Registered Medical Device, Registered CAB, Licensed Establishments under Section 5, 10, 15 of Medical Device Act 2012 (Act 737) respectively and Notified Medical Device under Medical Device (Exemption) Order 2016. Any party who wishes to know whether an establishment who is dealing with medical device has been licensed under Act 737 may search the establishment by inserting the establishment name or license number in the searching field below.


DEVICE DETAILS

NAME OF DEVICECERVICAL ORTHOSIS
ESTABLISHMENT NAMESOUTHERN CRESCENT SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGMD73262978519A
BRAND NAMEOPTEC
MEDICAL DEVICE CATEGORYREUSABLE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe 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 PURPOSEThe 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 REGISTRATION28/08/2024 - 27/08/2029

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
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