Home GUDID 07613327181531 INSTRUMENT
Primary DI 07613327181531
Brand INSTRUMENT
Company Howmedica Osteonics Corp.
Model 0901-1-000
Catalog number 0901-1-000
Device description HARDINGE CEMENT RESTRICTOR INTRODUCER
Published 2016-09-24
Public version status Update
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 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 07613327181531 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07613327181531 07613327181531 7613327181531
GMDN Terms# Term, Definition table Term Definition Orthopaedic implantable material dispenser, reservoir-containing A non-powered, syringe-/pipette-like device intended to load orthopaedic cement and/or a bone void filling material (not included) within an included reservoir/barrel and dispense the material during surgery. It is not designed to accept a separate cartridge/syringe or prepare/mix the substance. It may be intended to be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 058311945 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false 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 10888857615779 K2M General Instruments VB Spine LLC LXH 2026-10-28 M739193990906 Non-Modular Convex Trial CAPTIVA SPINE, INC. LXH 2026-10-28 M739193996906 Non-Modular Lordotic Trial Assembly CAPTIVA SPINE, INC. LXH 2026-10-28 M739243999005 SG Implant Driver-S CAPTIVA SPINE, INC. LXH 2026-10-28 M739985202229 Marking Pin CAPTIVA SPINE, INC. LXH 2026-10-28 M739985203229 Marking Pin CAPTIVA SPINE, INC. LXH 2026-10-28 00810055525164 NON NAVIGATED STYLET-OBTURATOR ASSEMBLY Si-Bone Inc. LXH 2026-10-27 00810055525188 CANNULATED PROBE IMPACTION CAP ASSEMBLY Si-Bone Inc. LXH 2026-10-27 00810055525195 CANNULATED PROBE HANDLE ASSEMBLY Si-Bone Inc. LXH 2026-10-27 00810055525218 GRANITE CANNULATED PROBE SHAFT Si-Bone Inc. LXH 2026-10-27 00889024702233 OsseoFit Zimmer, Inc. LXH 2026-10-27 00889024702240 OsseoFit Zimmer, Inc. LXH 2026-10-27 00889024702479 OsseoFit Zimmer, Inc. LXH 2026-10-27 00763000880118 MSB Reusable Instruments MEDTRONIC SOFAMOR DANEK, INC. LXH 2026-10-23 00842528130056 OSTEOMED OSTEOMED LLC LXH 2026-10-23 00888867550391 Arthrex® ARTHREX, INC. LXH 2026-10-23 00888867550407 Arthrex® ARTHREX, INC. LXH 2026-10-23 00888867550414 Arthrex® ARTHREX, INC. LXH 2026-10-23 00888867550421 Arthrex® ARTHREX, INC. LXH 2026-10-23 04251631412144 BEE PLIF NGMedical GmbH LXH 2026-10-23 M739153997700 Cross Connector Driver CAPTIVA SPINE, INC. LXH 2026-10-23 M739153998800 Cross Connector Counter Torque CAPTIVA SPINE, INC. LXH 2026-10-23 M739243501000 Blade Dilator CAPTIVA SPINE, INC. LXH 2026-10-23 M739243502000 Parallel Guide CAPTIVA SPINE, INC. LXH 2026-10-23 M739243503000 In-Line Handle CAPTIVA SPINE, INC. LXH 2026-10-23 M739243504000 Tissue Dilator CAPTIVA SPINE, INC. LXH 2026-10-23 M739243505000 Tissue Protector CAPTIVA SPINE, INC. LXH 2026-10-23 M739243506000 Adjustable Parallel Guide CAPTIVA SPINE, INC. LXH 2026-10-23 M739243507000 Impaction Sleeve CAPTIVA SPINE, INC. LXH 2026-10-23 M739243508000 Self-Feeding Drill CAPTIVA SPINE, INC. LXH 2026-10-23