Home GUDID 00822409082315 N/A
Primary DI 00822409082315
Brand N/A
Company Ortho Development Corporation
Model 233-0157
Device description Captured Bipolar Shell Trial 57mm
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 00822409082315 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 00822409082315 00822409082315 822409082315 0822409082315
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 00199150002139 N/A MEDTRONIC SOFAMOR DANEK, INC. LXH 2026-07-16 00199150002146 N/A MEDTRONIC SOFAMOR DANEK, INC. LXH 2026-07-16 00763000754730 N/A MEDTRONIC SOFAMOR DANEK, INC. LXH 2026-07-16 00763000754747 N/A MEDTRONIC SOFAMOR DANEK, INC. LXH 2026-07-16 00822409082124 N/A Ortho Development Corporation LXH 2026-07-16 00822409082131 N/A Ortho Development Corporation LXH 2026-07-16 00822409082148 N/A Ortho Development Corporation LXH 2026-07-16 00822409082155 N/A Ortho Development Corporation LXH 2026-07-16 00822409082162 N/A Ortho Development Corporation LXH 2026-07-16 00822409082179 N/A Ortho Development Corporation LXH 2026-07-16 00822409082186 N/A Ortho Development Corporation LXH 2026-07-16 00822409082193 N/A Ortho Development Corporation LXH 2026-07-16 00822409082209 N/A Ortho Development Corporation LXH 2026-07-16 00822409082216 N/A Ortho Development Corporation LXH 2026-07-16 00822409082223 N/A Ortho Development Corporation LXH 2026-07-16 00822409082230 N/A Ortho Development Corporation LXH 2026-07-16 00822409082247 N/A Ortho Development Corporation LXH 2026-07-16 00822409082254 N/A Ortho Development Corporation LXH 2026-07-16 00822409082261 N/A Ortho Development Corporation LXH 2026-07-16 00822409082278 N/A Ortho Development Corporation LXH 2026-07-16 00822409082285 N/A Ortho Development Corporation LXH 2026-07-16 00822409082292 N/A Ortho Development Corporation LXH 2026-07-16 00822409082308 N/A Ortho Development Corporation LXH 2026-07-16 00822409082322 N/A Ortho Development Corporation LXH 2026-07-16 00822409082339 N/A Ortho Development Corporation LXH 2026-07-16 00822409082346 N/A Ortho Development Corporation LXH 2026-07-16 00840606188135 Ventana A SPINAL ELEMENTS, INC. LXH 2026-07-16 00840606188142 Ventana A SPINAL ELEMENTS, INC. LXH 2026-07-16 00840606188159 Ventana A SPINAL ELEMENTS, INC. LXH 2026-07-16 00840606188166 Ventana A SPINAL ELEMENTS, INC. LXH 2026-07-16
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