Home GUDID 00817906027945 CoLink
Primary DI 00817906027945
Brand CoLink
Company In2Bones USA, LLC
Model P04 N0101
Catalog number P04 N0101
Device description Universal Plate Trial- 2-Hole
Published 2018-10-22
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name HRS Plate, Fixation, Bone HWC Screw, Fixation, Bone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HRS Plate, Fixation, Bone Orthopedic 2 HWC Screw, Fixation, Bone Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00817906027945 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 00817906027945 00817906027945 817906027945 0817906027945
GMDN Terms# Term, Definition table Term Definition Orthopaedic implant/trial-implant holder, reusable A hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft) or trial implant to facilitate guidance, gauging, and monitoring of the implant or trial implant during the orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic materials and is typically constructed in the form of a long shaft with a handle at the proximal end and an implant holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 079700711 Device count 1 Lot or batch true Manufacturing 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 00885556836187 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836163 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836170 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836194 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836200 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836217 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836224 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836248 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836255 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836262 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556835999 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836002 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836019 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836026 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836033 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836040 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836057 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836064 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836071 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836088 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836095 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836118 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836125 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836132 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836149 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836156 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556838785 Total Foot System 2 Smith & Nephew, Inc. HRS 2022-12-21 00885556838785 Total Foot System 2 Smith & Nephew, Inc. HWC 2022-12-21 00888867007475 Arthrex® ARTHREX, INC. HRS 2017-02-15 00888867007499 Arthrex® ARTHREX, INC. HRS 2017-02-15