Home GUDID 09348215072643 Trial BiPolar Head 22-39
Primary DI 09348215072643
Brand Trial BiPolar Head 22-39
Company SIGNATURE ORTHOPAEDICS PTY LTD
Model 112-24-0139
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 09348215072643 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09348215072643 09348215072643 9348215072643
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 09348215019587 Evolve AP Cup - Size 28-40 111-17-4028 2026-06-26 09348215019594 Evolve AP Cup - Size 28-42 111-17-4228 2026-06-26 09348215019600 Evolve AP Cup - Size 28-44 111-17-4428 2026-06-26 09348215019617 Evolve AP Cup - Size 28-46 111-17-4628 2026-06-26 09348215019624 Evolve AP Cup - Size 28-48 111-17-4828 2026-06-26 09348215019631 Evolve AP Cup - Size 28-50 111-17-5028 2026-06-26 09348215019648 Evolve AP Cup - Size 28-52 111-17-5228 2026-06-26 09348215019655 Evolve AP Cup - Size 28-54 111-17-5428 2026-06-26 09348215019662 Evolve AP Cup - Size 28-56 111-17-5628 2026-06-26 09348215046019 World Knee Cemented Titanium Tibial Plate - Modular - Size 1 - 40mm 121-20-4120 2026-06-26 09348215046026 World Knee Cemented Titanium Tibial Plate - Modular - Size 2 - 40mm 121-20-4220 2026-06-26 09348215046033 World Knee Cemented Titanium Tibial Plate - Modular - Size 3 - 40mm 121-20-4320 2026-06-26 09348215046040 World Knee Cemented Titanium Tibial Plate - Modular - Size 4 - 40mm 121-20-4420 2026-06-26 09348215046057 World Knee Cemented Titanium Tibial Plate - Modular - Size 5 - 40mm 121-20-4520 2026-06-26 09348215046064 World Knee Cemented Titanium Tibial Plate - Modular - Size 6 - 40mm 121-20-4620 2026-06-26 09348215046071 World Knee Cemented Titanium Tibial Plate - Modular - Size 7 - 40mm 121-20-4720 2026-06-26 09348215046088 World Knee Cemented Titanium Tibial Plate - Modular - Size 8 - 40mm 121-20-4820 2026-06-26 09348215046095 World Knee Cemented Titanium Tibial Plate - Modular - Size 9 - 40mm 121-20-4920 2026-06-26 09348215148980 Evolve AP Vit-E Cup – Neutral - Size 32-46 111-17-0146 2026-06-26 09348215148997 Evolve AP Vit-E Cup – Neutral - Size 32-48 111-17-0148 2026-06-26
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 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 07611996095647 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19