Home GUDID 00850011453483 REMEDY CoCr Modular Heads
Primary DI 00850011453483
Brand REMEDY CoCr Modular Heads
Company OSTEOREMEDIES, LLC
Model RHCCH44
Catalog number RHCCH44
Device description REMEDY® CoCr Modular Femoral Head - 44 mm
Published 2026-06-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
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
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
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850011453483 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 00850011453483 00850011453483 850011453483 0850011453483
GMDN Terms# Term, Definition table Term Definition Orthopaedic cement spacer A prefabricated device made of orthopaedic bone cement [e.g., polymethylmethacrylate (PMMA)], with an appropriate antibiotic, that is temporarily placed into a joint space to function as a carrier for the local delivery of antibiotic drugs and to prevent bone-on-bone contact and contraction of soft-tissue during surgical treatment of an infected joint. The shape and size of the device is modified to fit the joint space. This non-weight-bearing spacer remains in place until the infection clears; it is then removed and replaced with a conventional joint prosthesis. This is a single-use device.
Regulatory Flags# DUNS number 079596704 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product true Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# 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 00850011453476 REMEDY CoCr Modular Heads OSTEOREMEDIES, LLC KWL 2026-06-01 00850011453490 REMEDY CoCr Modular Heads OSTEOREMEDIES, LLC KWL 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 00850011453506 REMEDY Poly+Plus Acetabular Cup OSTEOREMEDIES, LLC KWL 2026-06-01 00850011453513 REMEDY Poly+Plus Acetabular Cup OSTEOREMEDIES, LLC KWY 2026-06-01 00850011453513 REMEDY Poly+Plus Acetabular Cup OSTEOREMEDIES, LLC KWL 2026-06-01 00850011453520 REMEDY Poly+Plus Acetabular Cup OSTEOREMEDIES, LLC KWY 2026-06-01 00850011453520 REMEDY Poly+Plus Acetabular Cup OSTEOREMEDIES, LLC KWL 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