Home GUDID 00810082898613 StealthFix Intraosseous Fixation System
Primary DI 00810082898613
Brand StealthFix Intraosseous Fixation System
Company Medartis Inc.
Model SF2402
Device description StealthFix STD 15 Drill Saw Guide LowPro
Published 2023-11-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810082898613 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 00810082898613 00810082898613 810082898613 0810082898613
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 192756786 Device count 1 Lot or batch true Manufacturing date on label true Expiration 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 00888867550292 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550308 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550315 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550322 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550339 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550346 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550353 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550360 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550377 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867550384 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552692 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552708 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552715 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552722 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552739 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552746 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552753 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867552760 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867574564 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867574571 Arthrex® ARTHREX, INC. LXH 2026-09-18 00888867574588 Arthrex® ARTHREX, INC. LXH 2026-09-18 04054896000831 Control Gauges Silony Medical GmbH LXH 2026-09-18 04054896000855 Implant Modifier Silony Medical GmbH LXH 2026-09-18 04054896000862 Implant Modifier Silony Medical GmbH LXH 2026-09-18 04054896000879 Implant Modifier Silony Medical GmbH LXH 2026-09-18 04054896000886 Forceps and Clamps Silony Medical GmbH LXH 2026-09-18 04054896000893 (Re-) Positioning Tools Silony Medical GmbH LXH 2026-09-18 04054896000909 (Re-) Positioning Tools Silony Medical GmbH LXH 2026-09-18 04054896000916 (Re-) Positioning Tools Silony Medical GmbH LXH 2026-09-18 04054896000923 Adapter Silony Medical GmbH LXH 2026-09-18