Home GUDID 09351327000053 Optimized Positioning System (OPS) and Optimized Postioning System (OPS) Femoral
Primary DI 09351327000053
Brand Optimized Positioning System (OPS) and Optimized Postioning System (OPS) Femoral
Company OPTIMIZED ORTHO PTY LTD
Model 1248-1500, 1248-1700, 1250-1100
Device description Patient Specific Acetabular Guide, Trial Acetabulum and Patient Specific Femoral Guide
Published 2019-04-18
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 09351327000053 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09351327000053 09351327000053 9351327000053
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