Home GUDID 00885556780039 VISIONAIRE
Primary DI 00885556780039
Brand VISIONAIRE
Company Smith & Nephew, Inc.
Model V0200128
Catalog number V0200128
Device description NONSTERILE VISIONAIRE UK MEDIAL GUIDE 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 false
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 00885556780039 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 00885556780039 00885556780039 885556780039 0885556780039
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.
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 false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00885556833933 Salto Talaris Total Ankle Prosthesis MJU952T MJU952T 2022-12-22 00885556833940 Salto Talaris Total Ankle Prosthesis MJU953T MJU953T 2022-12-22 00885556833957 Salto Talaris Total Ankle Prosthesis MJV219T MJV219T 2022-12-22 00885556833964 Salto Talaris Total Ankle Prosthesis MJV220T MJV220T 2022-12-22 00885556833971 Salto Talaris Total Ankle Prosthesis MJV221T MJV221T 2022-12-22 00885556833988 Salto Talaris Total Ankle Prosthesis MJV229T MJV229T 2022-12-22 00885556834237 Silicone Toe System CGT-205T CGT-205T 2022-12-22 00885556834251 Silicone Toe System CGT-305T CGT-305T 2022-12-22 00885556834299 Silicone Toe System CGT-505T CGT-505T 2022-12-22 00885556835029 Ti6 Internal Fixation System DS1007 DS1007 2022-12-22 00885556835203 Surgical Instruments FS-1006 FS-1006 2022-12-22 00885556836187 Ti6 Internal Fixation System TH3018 TH3018 2022-12-22 00885556837856 Total Foot System 2 2204250 2204250 2022-12-22 00885556838785 Total Foot System 2 2823027 2823027 2022-12-21 00885556841631 XT Revision Ankle Replacement System MJU984T MJU984T 2022-12-21 00885556841778 XT Revision Ankle Replacement System MJV222T MJV222T 2022-12-21 00885556841785 XT Revision Ankle Replacement System MJV223T MJV223T 2022-12-21 00885556854921 Freedom Wrist Arthroplasty System 348047 348047 2022-12-22 00885556856680 Surgical Instruments EXT-200-00 EXT-200-00 2022-12-22 00885556860168 Titan Modular Shoulder System 2.5 DRL-0923-047-001 DRL-0923-047-001 2022-12-22
Other Devices Sharing Product Codes# 
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