Home GUDID 10603295380597 ACTIS
Primary DI 10603295380597
Brand ACTIS
Company DEPUY (IRELAND)
Model 101012070
Catalog number 101012070
Device description ACTIS DUOFIX HIP PROSTHESIS (FEMORAL STEM 12/14 TAPER CEMENTLESS SIZE 7 HIGH COLLAR) CE
Published 2016-05-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name KWL Prosthesis, hip, hemi-, femoral, metal KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic 2 KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic 2 LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic 2 MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10603295380597 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10603295380597 10603295380597
GMDN Terms# Term, Definition table Term Definition Coated femoral stem prosthesis, one-piece A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.
Regulatory Flags# DUNS number 989365556 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07611996118674 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996074901 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074918 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074925 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074932 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074949 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074956 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074963 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074987 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074994 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996075014 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996075021 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095586 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095593 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095616 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095630 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095647 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095678 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095685 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996103410 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103410 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25 07611996103427 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25 07611996103434 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103441 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25 07611996103458 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25 07611996103465 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25 07611996103472 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25 07611996103489 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103489 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25 07611996103496 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25