Home GUDID 00822409122783 N/A
Primary DI 00822409122783
Brand N/A
Company Ortho Development Corporation
Model 613-4004A
Device description Neck Trial Keyed, STD, Size 8-9
Published 2024-04-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name MEH Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00822409122783 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 00822409122783 00822409122783 822409122783 0822409122783
GMDN Terms# Term, Definition table Term Definition Femoral stem prosthesis trial A copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral head trial prostheses. It is typically made of metal or polymer material and includes trial stems, trial sleeves, and trial necks. 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 Lot or batch true Manufacturing date on label true 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 07611996142334 POLARSTEM Smith & Nephew, Inc. MEH 2017-01-12 07611996142365 POLARSTEM Smith & Nephew, Inc. MEH 2017-01-12 07611996142372 POLARSTEM Smith & Nephew, Inc. MEH 2017-01-12 07611996142389 POLARSTEM Smith & Nephew, Inc. MEH 2017-01-12 07611996142396 POLARSTEM Smith & Nephew, Inc. MEH 2016-09-01 07611996103410 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103434 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103489 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103496 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103502 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103519 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103533 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103540 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996152692 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-25 07611996103373 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-22 07611996103380 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-22 07611996103397 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-22 07611996103403 POLARSTEM Smith & Nephew, Inc. MEH 2016-07-22 07613153071273 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071280 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071297 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071310 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071327 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071334 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071341 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071358 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071365 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071372 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071396 Restoration Howmedica Osteonics Corp. MEH 2015-09-24 07613153071402 Restoration Howmedica Osteonics Corp. MEH 2015-09-24
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