Home GUDID 10381780065838 Katalyst™ Bipolar Radial Head System
Primary DI 10381780065838
Brand Katalyst™ Bipolar Radial Head System
Company Ascension Orthopedics, Inc.
Model 221800
Catalog number 221800
Device description The Katalyst Set Screw is used to lock the Radial Head and the Radial Stem in place.
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 KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10381780065838 Primary GS1 0 M2482218001 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780065838 10381780065838
GMDN Terms# Term, Definition table Term Definition Elbow radius prosthesis A sterile implantable device designed to replace the proximal radius typically as treatment for severe radial head fracture or degenerative disease (arthritis). The device includes a radial head or radial head with stem and is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] or metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.
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 Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Regulatory Flags# DUNS number 942377524 Device count 1 Lot or batch true Manufacturing date on label 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 00885556830543 PyroCarbon Modular Radial Head Smith & Nephew, Inc. KWI 2026-09-24 00885556830550 PyroCarbon Modular Radial Head Smith & Nephew, Inc. KWI 2026-09-24 00885556830567 PyroCarbon Modular Radial Head Smith & Nephew, Inc. KWI 2026-09-24 00885556830574 PyroCarbon Modular Radial Head Smith & Nephew, Inc. KWI 2026-09-24 00888867570764 Arthrex® ARTHREX, INC. KWI 2026-09-21 00888867570771 Arthrex® ARTHREX, INC. KWI 2026-09-21 00888867568044 Arthrex® ARTHREX, INC. KWI 2026-09-17 00888867568051 Arthrex® ARTHREX, INC. KWI 2026-09-17 00888867568068 Arthrex® ARTHREX, INC. KWI 2026-09-17 00888867568075 Arthrex® ARTHREX, INC. KWI 2026-09-17 00888867568082 Arthrex® ARTHREX, INC. KWI 2026-09-17 00888867568099 Arthrex® ARTHREX, INC. KWI 2026-09-17 00888867568129 Arthrex® ARTHREX, INC. KWI 2026-09-17 00885556827307 Katalyst Bipolar Radial Head System Smith & Nephew, Inc. KWI 2022-12-21 00885556827314 Katalyst Bipolar Radial Head System Smith & Nephew, Inc. KWI 2022-12-21 00885556827338 Katalyst Biopolar Radial Head System Smith & Nephew, Inc. KWI 2022-12-21 00885556827345 Katalyst Biopolar Radial Head System Smith & Nephew, Inc. KWI 2022-12-21 10886982300713 NA Synthes GmbH KWI 2020-06-17 10886982300720 NA Synthes GmbH KWI 2020-06-17 10886982300522 NA Synthes GmbH KWI 2020-06-08 10886982300539 NA Synthes GmbH KWI 2020-06-08 10886982300546 NA Synthes GmbH KWI 2020-06-08 10886982300553 NA Synthes GmbH KWI 2020-06-08 10886982300560 NA Synthes GmbH KWI 2020-06-08 10886982300577 NA Synthes GmbH KWI 2020-06-08 10886982300584 NA Synthes GmbH KWI 2020-06-08 10886982300591 NA Synthes GmbH KWI 2020-06-08 10886982300607 NA Synthes GmbH KWI 2020-06-08 10886982300614 NA Synthes GmbH KWI 2020-06-08 10886982300621 NA Synthes GmbH KWI 2020-06-08
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