Home GUDID 00815500024537 Dymaxeon
Primary DI 00815500024537
Brand Dymaxeon
Company BACK 2 BASIC DIRECT, LLC
Model 05.5
Catalog number 06.6606B-1
Device description DYMAXEON PEDICLE SCREW - CANNULATED - CAP INCLUDED Ø7.5 x 70mm (VIOLET)
Published 2019-02-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name MNH Orthosis, Spondylolisthesis Spinal Fixation MNI Orthosis, Spinal Pedicle Fixation NKB Thoracolumbosacral Pedicle Screw System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2 MNI Orthosis, Spinal Pedicle Fixation Orthopedic 2 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00815500024537 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00815500024537 00815500024537 815500024537 0815500024537
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, sterile An assembly of 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. Sterile disposable devices associated with implantation may be included.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 0 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 043841348 Device count 1 DM exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 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 00840606174855 Primus SPINAL ELEMENTS, INC. NKB 2026-10-22 00840606175142 Primus SPINAL ELEMENTS, INC. NKB 2026-10-22 00840606175203 Primus SPINAL ELEMENTS, INC. NKB 2026-10-22
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