Home GUDID 00885556779989 VISIONAIRE
Primary DI 00885556779989
Brand VISIONAIRE
Company Smith & Nephew, Inc.
Model V0100128
Catalog number V0100128
Device description VISIONAIRE UK MEDIALGUIDE KIT
Published 2021-09-22
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name HSX PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER MBH PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER OOG Knee arthroplasty implantation system
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic 2 JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic 2 MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic 2 OOG Knee Arthroplasty Implantation System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00885556779989 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 00885556779989 00885556779989 885556779989 0885556779989
GMDN Terms# Term, Definition table Term Definition Custom-made orthopaedic/craniofacial surgical guide A custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is typically 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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 045483575 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00885556925171 REAL INTELLIGENCE ROB100021F ROB100021F 2026-07-30 00885556925188 REAL INTELLIGENCE ROB100022F ROB100022F 2026-07-30 00885556919743 Real Intelligence ROB30003 ROB30003 2026-03-10 00885556919767 Real Intelligence ROB30005 ROB30005 2026-03-10 20885556628908 Navio PFSDV0016 PFSDV0016 2016-09-21 00885556820964 General Instruments MA3511ND MA3511ND 2023-10-27 00885556822722 Capture High Torque Screw System MAT-000-02 MAT-000-02 2022-12-21 00885556822937 Total Foot System 2 321010 321010 2022-12-21 00885556822944 Total Foot System 2 321012 321012 2022-12-21 00885556828090 XT Revision Ankle Replacement System MJV551T MJV551T 2022-12-21 00885556832431 Salto Talaris Total Ankle Prosthesis MJU012T MJU012T 2022-12-21 00885556837825 Total Foot System 2 382000 382000 2022-12-22 00885556840375 Total Wrist Fusion System 303511 303511 2022-12-21 00885556841525 XT Revision Ankle Replacement System MJU944T MJU944T 2022-12-21 00885556855003 Freedom Wrist Arthroplasty System 348059 348059 2022-12-22 00885556858301 PyroCarbon PIP Total Joint System OSG-200-00 OSG-200-00 2022-12-22 00885556858325 PyroCarbon PIP Total Joint System OSG-200-10PV OSG-200-10PV 2022-12-22 00885556858349 PyroCarbon PIP Total Joint System OSG-200-20PV OSG-200-20PV 2022-12-22 00885556858363 PyroCarbon PIP Total Joint System OSG-200-30PV OSG-200-30PV 2022-12-22 00885556858387 PyroCarbon PIP Total Joint System OSG-200-40PV OSG-200-40PV 2022-12-22
Other Devices Sharing Product Codes# 
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