Home GUDID 10381780236481 Integra® PyroSphere®
Primary DI 10381780236481
Brand Integra® PyroSphere®
Company Ascension Orthopedics, Inc.
Model TRL43540
Catalog number TRL-435-40
Device description Trial used to evaluate the size and fit of the implant.
Published 2016-08-15
Public version status Update
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 10381780236481 Primary GS1 0 M269TRL435401 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780236481 10381780236481
GMDN Terms# Term, Definition table Term Definition Carpometacarpal interpositional spacer prosthesis trial A sterile copy of a final carpometacarpal interpositional spacer prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient, and to ensure its proper orientation and positioning. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 942377524 Device count 1 Lot or batch true Sterilization required before use true Other Devices From This Company# 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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