Home GUDID 00822409082148 N/A
Primary DI 00822409082148
Brand N/A
Company Ortho Development Corporation
Model 233-0140
Device description Captured Bipolar Shell Trial 40mm
Published 2026-07-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name LXH Orthopedic manual surgical instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00822409082148 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 00822409082148 00822409082148 822409082148 0822409082148
GMDN Terms# Term, Definition table Term Definition Acetabulum prosthesis trial, prefabricated, reusable A copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 876542390 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 00810055525751 Onyx Dual End Set Screw Starter Si-Bone Inc. LXH 2026-10-06 B7685216080 Buxton Biomedical, Inc BUXTON BIOMEDICAL, INC. LXH 2026-10-06 00810228161731 corra Carlsmed, Inc. LXH 2026-10-05 00840493441641 LUX Expandable Interbody System XENIX MEDICAL LLC LXH 2026-10-05 00840493441658 LUX Expandable Interbody System XENIX MEDICAL LLC LXH 2026-10-05 00840493441696 RIVA Pedicle Screw System XENIX MEDICAL LLC LXH 2026-10-05 00840493442020 Xenix Medical Universal Handle XENIX MEDICAL LLC LXH 2026-10-05 00840493442037 Xenix Medical Universal Handle XENIX MEDICAL LLC LXH 2026-10-05 00888867620612 Arthrex® ARTHREX, INC. LXH 2026-10-01 00888867620629 Arthrex® ARTHREX, INC. LXH 2026-10-01 00888867620636 Arthrex® ARTHREX, INC. LXH 2026-10-01 00888867620643 Arthrex® ARTHREX, INC. LXH 2026-10-01 M7401001380 OptiLIF Endo, Direct Visualization System SPINEOLOGY INC. LXH 2026-10-01 00840606191425 Primus SPINAL ELEMENTS, INC. LXH 2026-09-30 00840606191432 Primus SPINAL ELEMENTS, INC. LXH 2026-09-30 00840606191449 Primus SPINAL ELEMENTS, INC. LXH 2026-09-30 00840606191456 Primus SPINAL ELEMENTS, INC. LXH 2026-09-30 00810017915668 SABER-XA, Trial Inserter ELEVATION SPINE, INC. LXH 2026-09-29 00810017916030 SABER-XA Straight Awl, Self-Guided ELEVATION SPINE, INC. LXH 2026-09-29 00810055525300 Onyx 4.5mm Cannulated Tap Si-Bone Inc. LXH 2026-09-29 00810055525317 Onyx 5.5mm Cannulated Tap Si-Bone Inc. LXH 2026-09-29 00810055525324 Onyx 6.5mm Cannulated Tap Si-Bone Inc. LXH 2026-09-29 00810055525331 Onyx 7.5mm Cannulated Tap Si-Bone Inc. LXH 2026-09-29 00810055525348 Onyx 4.5MM Awl Tip Tap Si-Bone Inc. LXH 2026-09-29 00810055525355 Onyx 5.5MM Awl Tip Tap Si-Bone Inc. LXH 2026-09-29 00810055525362 Onyx 6.5MM Awl Tip Tap Si-Bone Inc. LXH 2026-09-29 00810055525379 Onyx 7.5MM Awl Tip Tap Si-Bone Inc. LXH 2026-09-29 00810055525386 Onyx Feeler Probe Si-Bone Inc. LXH 2026-09-29 00810055525393 Onyx Straight Probe Si-Bone Inc. LXH 2026-09-29 00810055525409 Onyx Curved Probe Si-Bone Inc. LXH 2026-09-29
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