Home GUDID 00840606190671 Primus
Primary DI 00840606190671
Brand Primus
Company SPINAL ELEMENTS, INC.
Model 66675-020
Device description Primus T27 MIS Set Screw Driver
Published 2026-10-26
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 00840606190671 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 00840606190671 00840606190671 840606190671 0840606190671
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning instrument, reusable A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 610712213 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 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 00840606174855 Primus SPINAL ELEMENTS, INC. NKB 2026-10-22