Home GUDID 07612334213778 NA
Primary DI 07612334213778
Brand NA
Company Synthes GmbH
Model 09.405.283S
Catalog number 09405283S
Device description RADIAL HEAD W/ Ø22MM HD, Ø8.5MM STM,10(+3)MM HD HT,STER
Published 2020-06-17
Public version status Update
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 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 07612334213778 Direct Marking GS1 0 10886982300713 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07612334213778 07612334213778 7612334213778 10886982300713 10886982300713
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.
Regulatory Flags# DUNS number 486711679 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false 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 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 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 10886982300638 NA Synthes GmbH KWI 2020-06-08
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