Home GUDID 00888118129529 IPS
Primary DI 00888118129529
Brand IPS
Company KLS-Martin L.P.
Model 60-004-37-09
Device description MARKING GUIDE, ORTHOG, XL
Published 2021-02-22
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 true Product Codes# Code, Name table Code Name DZJ DRIVER, WIRE, AND BONE DRILL, MANUAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DZJ Driver, Wire, And Bone Drill, Manual Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00888118129529 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 00888118129529 00888118129529 888118129529 0888118129529
GMDN Terms# Term, Definition table Term Definition Custom-made organ/bone anatomy model/surgical guide kit A collection of custom-made devices intended to be used to assist anatomical visualization, surgical treatment planning, and intraoperative surgical procedures (e.g., orientation of implant components, guiding of surgical instruments). It consists of an anatomy model(s) of an organ/bone and an orthopaedic/craniomaxillofacial surgical guide(s) [e.g., for osteotomy, arthroplasty]; it is made of synthetic polymer materials and is manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 826499238 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true 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 00888118154231 IPS KLS-Martin L.P. DZJ 2026-05-25 00888118149572 IPS KLS-Martin L.P. DZJ 2026-02-23 00888118149589 IPS KLS-Martin L.P. DZJ 2026-02-23 00888118149626 IPS KLS-Martin L.P. DZJ 2026-02-23 00888118149336 IPS KLS-Martin L.P. DZJ 2025-11-26 05420060380839 TRUMATCH Materialise NV DZJ 2025-09-11 05420060380846 TRUMATCH Materialise NV DZJ 2025-09-11 05420060380853 TRUMATCH Materialise NV DZJ 2025-09-11 05420060380860 TRUMATCH Materialise NV DZJ 2025-09-11 05420060380877 TRUMATCH Materialise NV DZJ 2025-09-11 05420060380884 TRUMATCH Materialise NV DZJ 2025-09-11 05420060380891 TRUMATCH Materialise NV DZJ 2025-09-11 05420060380907 TRUMATCH Materialise NV DZJ 2025-09-11 00840124519633 PolyLock FUSION ORTHOPEDICS, LLC DZJ 2025-05-15 00840124519640 PolyLock FUSION ORTHOPEDICS, LLC DZJ 2025-05-15 00840124519893 PolyLock Midfoot FUSION ORTHOPEDICS, LLC DZJ 2025-05-15 00840124519909 PolyLock Midfoot FUSION ORTHOPEDICS, LLC DZJ 2025-05-15 00840124519916 PolyLock Midfoot FUSION ORTHOPEDICS, LLC DZJ 2025-05-15 00888118145086 IPS KLS-Martin L.P. DZJ 2025-04-22 00888118145093 IPS KLS-Martin L.P. DZJ 2025-04-22 00888118145543 IPS KLS-Martin L.P. DZJ 2025-04-22 00888118145550 IPS KLS-Martin L.P. DZJ 2025-04-22 00888118145567 IPS KLS-Martin L.P. DZJ 2025-04-22 00860012759446 TECHFIT Techfit Digital Surgery, Inc. DZJ 2025-03-17 00860012759453 TECHFIT Techfit Digital Surgery, Inc. DZJ 2025-03-17 00860012759460 TECHFIT Techfit Digital Surgery, Inc. DZJ 2025-03-17 05420060380747 TRUMATCH Materialise NV DZJ 2025-02-28 05420060380754 TRUMATCH Materialise NV DZJ 2025-02-28 05420060380761 TRUMATCH Materialise NV DZJ 2025-02-28 00840124514416 FuzeFix Chamfered Screws FUSION ORTHOPEDICS, LLC DZJ 2024-12-04
klsmartin.com