Home GUDID 00814703012099 Klassic BiPolar Head, 57 mm OD, 28 mm Head
Primary DI 00814703012099
Brand Klassic BiPolar Head, 57 mm OD, 28 mm Head
Company TOTAL JOINT ORTHOPEDICS, INC.
Model 3205.57.028
Published 2015-10-22
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 00814703012099 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00814703012099 00814703012099 814703012099 0814703012099
GMDN Terms# Term, Definition table Term Definition Femoral head bipolar component A sterile 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., titanium alloy) and an inner polyethylene (PE) liner; it is typically used for older femoral fracture patients.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 The Klassic BiPolar System Implants should be stored in a clean, dry location at
room temperature Special Storage Condition, Specify 0 0 The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 078416717 Device count 1 Lot or batch true Expiration date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810094692940 AP Sizer with Short Legs SRI-10050 2026-05-15 00810094692728 CR Femoral Trial, Grit Blasted SRI-10051.01 2026-02-05 00810094692735 CR Femoral Trial, Grit Blasted SRI-10051.02 2026-02-05 00810094692742 CR Femoral Trial, Grit Blasted SRI-10051.03 2026-02-05 00810094692759 CR Femoral Trial, Grit Blasted SRI-10051.04 2026-02-05 00810094692766 CR Femoral Trial, Grit Blasted SRI-10051.05 2026-02-05 00810094692773 CR Femoral Trial, Grit Blasted SRI-10051.06 2026-02-05 00810094692780 CR Femoral Trial, Grit Blasted SRI-10051.07 2026-02-05 00810094692506 Tibial Broach Impactor, Revision 2904.00.000 2025-05-14 00810094692278 Universal Cone Impactor Head 2021.12.012 2025-04-24 00810094692285 Universal Cone Impactor Head 2021.34.018 2025-04-24 00810094692292 Universal Cone Impactor Head 2021.57.024 2025-04-24 00810094691950 Universal Cone Impactor Head, Size 1, 12° 2021.01.012 2024-09-06 00810094691967 Universa Cone Impactor Head, Size 2, 12° 2021.02.012 2024-09-06 00810094691974 Universal Cone Impactor Head, Size 3, 18° 2021.03.018 2024-09-06 00810094691981 Universal Cone Impactor Head, Size 4, 18° 2021.04.018 2024-09-06 00810094691998 Universal Cone Impactor Head, Size 5, 24° 2021.05.024 2024-09-06 00810094692001 Universal Cone Impactor Head, Size 6, 24° 2021.06.024 2024-09-06 00810094692018 Universal Cone Impactor Head, Size 7, 24° 2021.07.024 2024-09-06 00819251021197 Femoral Stem Impactor with Anteversion 1307.00.000 2023-12-11
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 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 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. KWY 2016-07-25 07611996103427 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25 07611996103441 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25 07611996103458 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25
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