Home GUDID 08800037522603 Perfix™ Spinal System
Primary DI 08800037522603
Brand Perfix™ Spinal System
Company CG MedTech Co.,Ltd.
Model SR6200TSL
Published 2019-10-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name MNH Orthosis, spondylolisthesis spinal fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800037522603 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800037522603 08800037522603 8800037522603
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 688811082 Device count 1 DM exempt true Lot or batch true Serial number true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B678520297S0 PressON™ NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520298S0 PressON™ NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520299S0 PressON NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520300S0 PressON™ NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520301S0 PressON NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520302S0 PressON™ NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520303S0 PressON NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520304S0 PressON™ NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520305S0 PressON NEXUS SPINE, L.L.C. MNH 2026-07-10 B678520306S0 PressON™ NEXUS SPINE, L.L.C. MNH 2026-07-10 00643169465879 MSB CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2026-06-28 10889981065348 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02 10889981065539 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02 10889981065553 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02 10889981065577 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02 10889981065584 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02 10889981065607 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02 10889981065645 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02 10889981065669 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02 10889981065683 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02 10889981065706 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02 10889981065720 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02 10889981065744 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02 10889981065768 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02 10889981065782 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02 10889981065805 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02 10889981065829 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02 10889981065843 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02 10889981065867 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02 10889981065881 Mariner Seaspine Orthopedics Corporation MNH 2016-09-02