Home GUDID 09348215072636 Trial BiPolar Head 22-38
Primary DI 09348215072636
Brand Trial BiPolar Head 22-38
Company SIGNATURE ORTHOPAEDICS PTY LTD
Model 112-24-0138
Published 2020-06-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 09348215072636 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09348215072636 09348215072636 9348215072636
GMDN Terms# Term, Definition table Term Definition Surgical implant template, reusable A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 751993028 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use 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