Home GUDID 09348215017293 Signature BiPolar Head
Primary DI 09348215017293
Brand Signature BiPolar Head
Company SIGNATURE ORTHOPAEDICS PTY LTD
Model 111-21-2842
Published 2018-04-30
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 KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 09348215017293 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09348215017293 09348215017293 9348215017293
GMDN Terms# Term, Definition table Term Definition Bipolar femoral head outer component, hemiarthroplasty An implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and an inner polyethylene (PE) liner.
Regulatory Flags# DUNS number 751993028 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 09348215185428 Signature Magnum Acetabular Cup 111-67-0044 2026-07-29 09348215185435 Signature Magnum Acetabular Cup 111-67-0046 2026-07-29 09348215185442 Signature Magnum Acetabular Cup 111-67-0048 2026-07-29 09348215185459 Signature Magnum Acetabular Cup 111-67-0050 2026-07-29 09348215185466 Signature Magnum Acetabular Cup 111-67-0052 2026-07-29 09348215185473 Signature Magnum Acetabular Cup 111-67-0054 2026-07-29 09348215185480 Signature Magnum Acetabular Cup 111-67-0056 2026-07-29 09348215185497 Signature Magnum Acetabular Cup 111-67-0058 2026-07-29 09348215185503 Signature Magnum Acetabular Cup 111-67-0060 2026-07-29 09348215185510 Signature Magnum Acetabular Cup 111-67-0062 2026-07-29 09348215185527 Signature Magnum Acetabular Cup 111-67-0064 2026-07-29 09348215185534 Signature Magnum Acetabular Cup 111-67-0066 2026-07-29 09348215185541 Signature Resurfacing Femoral Head 111-67-0138 2026-07-29 09348215185558 Signature Resurfacing Femoral Head 111-67-0140 2026-07-29 09348215185565 Signature Resurfacing Femoral Head 111-67-0142 2026-07-29 09348215185572 Signature Resurfacing Femoral Head 111-67-0144 2026-07-29 09348215185589 Signature Resurfacing Femoral Head 111-67-0146 2026-07-29 09348215185596 Signature Resurfacing Femoral Head 111-67-0148 2026-07-29 09348215185602 Signature Resurfacing Femoral Head 111-67-0150 2026-07-29 09348215185619 Signature Resurfacing Femoral Head 111-67-0152 2026-07-29
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00889024707467 Z1® Hip System Zimmer, Inc. KWY 2026-07-29 00850011453476 REMEDY CoCr Modular Heads OSTEOREMEDIES, LLC KWY 2026-06-01 00850011453483 REMEDY CoCr Modular Heads OSTEOREMEDIES, LLC KWY 2026-06-01 00850011453490 REMEDY CoCr Modular Heads OSTEOREMEDIES, LLC KWY 2026-06-01 00850011453506 REMEDY Poly+Plus Acetabular Cup OSTEOREMEDIES, LLC KWY 2026-06-01 00850011453513 REMEDY Poly+Plus Acetabular Cup OSTEOREMEDIES, LLC KWY 2026-06-01 00850011453520 REMEDY Poly+Plus Acetabular Cup OSTEOREMEDIES, LLC KWY 2026-06-01 07611996118674 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142327 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142334 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142341 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142358 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142365 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142372 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142389 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