Home GUDID 10381780114611 Ascension® PyroSphere
Primary DI 10381780114611
Brand Ascension® PyroSphere
Company Ascension Orthopedics, Inc.
Model PCS43040WW
Catalog number PCS-430-40-WW
Device description Single-use, spherical, interpositional prosthesis for the basal thumb joint.
Published 2017-10-09
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 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 10381780114611 Primary GS1 0 M268PCS43040WW1 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780114611 10381780114611
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.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Regulatory Flags# DUNS number 942377524 Device count 1 Lot or batch true Expiration date on label 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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