Home GUDID 09351327000046 Optimized Ortho Positioning (OPS) Femoral
Primary DI 09351327000046
Brand Optimized Ortho Positioning (OPS) Femoral
Company OPTIMIZED ORTHO PTY LTD
Model 1250-1200
Device description Trial Femoral Head
Published 2019-04-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate PBF Orthopaedic Surgical Planning And Instrument Guides
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic 2 LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic 2 MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic 2 PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 09351327000046 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09351327000046 09351327000046 9351327000046
GMDN Terms# Term, Definition table Term Definition Custom-made orthopaedic surgical guide, non-sterile A non-sterile, 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 made of synthetic polymer materials and 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 intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 745735175 Device count 1 Lot or batch true Expiration 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 07611996074901 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074918 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074925 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074932 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074932 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074949 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074949 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074956 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074963 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074970 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996074970 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074987 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074994 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996074994 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996075007 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996075007 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996075014 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996075014 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996075021 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996075038 SL-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996075038 SL-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095586 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095586 SLR-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996095593 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095593 SLR-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996095609 SLR-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996095609 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095616 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19 07611996095623 SLR-PLUS Smith & Nephew, Inc. LWJ 2016-08-19 07611996095623 SLR-PLUS Smith & Nephew, Inc. LZO 2016-08-19