Home GUDID 08809974437544 Hedjet System
Primary DI 08809974437544
Brand Hedjet System
Company Medyssey Co., Ltd.
Model 15DZRPS4030
Device description Hedjet 15mm Reduction Poly axial Screw 4.0x30mm, Ø5.5mm Rod
Published 2023-10-04
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name NKB Thoracolumbosacral Pedicle Screw System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08809974437544 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08809974437544 08809974437544 8809974437544
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 688211503 Device count 1 Lot or batch true Manufacturing date on label 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 00840606190671 Primus SPINAL ELEMENTS, INC. NKB 2026-10-26 04047844130957 DIPLOMAT SIGNUS Medizintechnik GmbH NKB 2026-10-26 04047844130964 DIPLOMAT SIGNUS Medizintechnik GmbH NKB 2026-10-26 00763000777500 MSB CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2026-10-25 00763000777623 MSB CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2026-10-25 00763000786434 MSB CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2026-10-25 00763000749903 CD HORIZON® Fenestrated Screw Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2026-10-23 00763000750510 CD HORIZON® Fenestrated Screw Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2026-10-23 00763000777616 CD HORIZON® Fenestrated Screw Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2026-10-23 03701313009632 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009649 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009656 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009663 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009670 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009687 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009694 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009700 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009717 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009724 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009731 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009748 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009755 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009762 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009779 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009786 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009793 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313009809 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313010027 KHEIRON S.M.A.I.O NKB 2026-10-23 03701313010034 KHEIRON S.M.A.I.O NKB 2026-10-23 00840466901011 Primus SPINAL ELEMENTS, INC. NKB 2026-10-22