Home GUDID 00888912133579 DJO SURGICAL
Primary DI 00888912133579
Brand DJO SURGICAL
Company Encore Medical, L.P.
Model 801-04-020
Device description SL TIBIAL STEM REAMER - TRAPEZOID
Published 2024-09-18
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 HTO REAMER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTO Reamer Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00888912133579 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 00888912133579 00888912133579 888912133579 0888912133579
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 154074504 Device count 1 Premarket exempt true Lot or batch true No natural rubber latex 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 00840096408690 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408706 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408713 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408720 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408737 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408744 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408751 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408768 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408775 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408782 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408799 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408805 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408812 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408829 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408836 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408843 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408850 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408867 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408874 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408881 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408898 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408904 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408911 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408928 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408935 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408942 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408959 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408966 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408973 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03 00840096408980 Viant Medical, LLC VIANT MEDICAL HTO 2020-09-03