Home GUDID 00810063560089 Ensemble CMC
Primary DI 00810063560089
Brand Ensemble CMC
Company Ensemble Orthopedics, Inc.
Model Ensemble CMC Implant Holder
Catalog number 103-HLD-001
Published 2021-10-11
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name KYI Prosthesis, Wrist, Carpal Trapezium
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KYI Prosthesis, Wrist, Carpal Trapezium Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810063560089 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 00810063560089 00810063560089 810063560089 0810063560089
GMDN Terms# Term, Definition table Term Definition Metacarpal prosthesis A sterile implantable device designed to replace the proximal end (base) of the first metacarpal of the thumb carpometacarpal (CMC) joint (articulation with the trapezium) typically to treat thumb instability/motion disabilities caused by arthritis or fracture. It is typically a one-piece device, made of one or several materials (e.g., carbon, graphite, metal); implantation may be performed with our without bone cement.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 004115364 Device count 1 Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810063560232 Ensemble CMC Ensemble CMC Trapezium Rasp 103-RSP-005 2025-05-06 00810063560201 Ensemble CMC Ensemble CMC Bump Rasp 103-RSP-003 2023-08-01 00810063560003 Ensemble CMC Ensemble CMC Implant, Size 141 101-CMC-141 2021-03-30 00810063560010 Ensemble CMC Ensemble CMC Implant, Size 151 101-CMC-151 2021-03-30 00810063560027 Ensemble CMC Ensemble CMC Implant, Size 161 101-CMC-161 2021-03-30 00810063560034 Ensemble CMC Ensemble CMC Peripheral Rasp 103-RSP-001 2021-03-30 00810063560041 Ensemble CMC Ensemble CMC Saddle Rasp 103-RSP-002 2021-03-30 00810063560058 Ensemble CMC Ensemble CMC Trial, Size 141 103-TRL-141 2021-03-30 00810063560065 Ensemble CMC Ensemble CMC Trial, Size 151 103-TRL-151 2021-03-30 00810063560072 Ensemble CMC Ensemble CMC Trial, Size 161 103-TRL-161 2021-03-30 00810063560096 Ensemble CMC Ensemble Instrument Tray 103-INS-001 2021-03-30
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810063560232 Ensemble CMC Ensemble Orthopedics, Inc. KYI 2025-05-06 M209177990 THUMB MOD HEAD TITANIUM 13MM+2 BIOPRO, INC. KYI 2024-06-30 M209178000 THUMB MOD HEAD TITANIIUM 12MM BIOPRO, INC. KYI 2024-06-30 M209178010 THUMB MOD HEAD TITANIUM 12MM+2 BIOPRO, INC. KYI 2024-06-30 M209178060 THUMB MOD HEAD TITANIUM 14MM BIOPRO, INC. KYI 2024-06-30 M209178070 THUMB MOD HEAD TITANIUM 14MM+2 BIOPRO, INC. KYI 2024-06-30 M209178080 THUMB MOD HEAD TITANIUM 15MM BIOPRO, INC. KYI 2024-06-30 M209178090 THUMB MOD HEAD TITANIUM 15MM+2 BIOPRO, INC. KYI 2024-06-30 M209177980 THUMB MOD HEAD TITANIUM 13MM BIOPRO, INC. KYI 2024-05-30 00810063560201 Ensemble CMC Ensemble Orthopedics, Inc. KYI 2023-08-01 00885556830789 PyroSphere CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556830840 PyroSphere CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556830857 PyroSphere CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556830864 PyroSphere CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556830871 PyroSphere CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556830888 PyroSphere CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556857748 NuGrip CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556857755 NuGrip CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556857762 NuGrip CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556857779 NuGrip CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556857786 NuGrip CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556857793 NuGrip CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556857809 NuGrip CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556857816 NuGrip CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556857823 NuGrip CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556857915 NuGrip CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556857922 NuGrip CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556857939 NuGrip CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556857946 NuGrip CMC Smith & Nephew, Inc. KYI 2022-12-22 00885556857953 NuGrip CMC Smith & Nephew, Inc. KYI 2022-12-22
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