Home GUDID 00888118144553 IPS
Primary DI 00888118144553
Brand IPS
Company KLS-Martin L.P.
Model 60-000-42-09-PP
Device description IMPLANT, MANDIBLE, ONLAY, 00042, ALT, PEEK
Published 2024-10-08
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name GXN PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE GXP METHYL METHACRYLATE FOR CRANIOPLASTY JEY PLATE, BONE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GXN Plate, Cranioplasty, Preformed, Non-Alterable Neurology 2 GXP Methyl Methacrylate For Cranioplasty Neurology 2 JEY Plate, Bone Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00888118144553 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 00888118144553 00888118144553 888118144553 0888118144553
GMDN Terms# Term, Definition table Term Definition Custom-made cranial bone prosthesis An implantable device intended to repair a defect of the cranium or mandible that is designed and constructed with specific characteristics (e.g., size, shape, material) as prescribed by a healthcare provider for a specified patient. It is typically manufactured from a three-dimensional (3-D) model based on computed tomography (CT) images and made of plastic [e.g., ultrahigh molecular weight polyethylene (UHMWPE), polyetheretherketone (PEEK)] and/or metal [e.g., titanium (Ti)]. The device may be used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease, or for cosmetic/aesthetic purposes.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 826499238 Device count 1 Lot or batch true Serial number 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 00810188324924 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-09 00810188324702 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-07 00810188324818 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-06-26 00810188324849 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-06-26 00810188324856 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-06-26 04046826346812 Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft JEY 2026-06-25 04046826416676 Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft JEY 2026-06-25 04046826542337 Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft JEY 2026-06-25 04046826543655 Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft JEY 2026-06-25 04046826552473 Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft JEY 2026-06-25 00810188324672 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-06-22 00810188324757 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-06-22 00810188324788 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-06-22 00888118126528 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2020-04-22 10888118113600 LEVEL ONE CMF KLS-Martin L.P. JEY 2017-10-20 10888118113617 LEVEL ONE CMF KLS-Martin L.P. JEY 2017-10-20 00888118001825 LEVEL ONE CMF KLS-Martin L.P. JEY 2016-03-24 00888118001870 LEVEL ONE CMF KLS-Martin L.P. JEY 2016-03-24 00888118002129 LEVEL ONE CMF KLS-Martin L.P. JEY 2016-03-24 00888118002136 LEVEL ONE CMF KLS-Martin L.P. JEY 2016-03-24 00888118003041 LEVEL ONE CMF KLS-Martin L.P. JEY 2016-03-24 00888118003058 LEVEL ONE CMF KLS-Martin L.P. JEY 2016-03-24 00888118003751 LEVEL ONE CMF KLS-Martin L.P. JEY 2016-03-24 00888118003775 LEVEL ONE CMF KLS-Martin L.P. JEY 2016-03-24 00888118003782 LEVEL ONE CMF KLS-Martin L.P. JEY 2016-03-24 00888118003799 LEVEL ONE CMF KLS-Martin L.P. JEY 2016-03-24 00888118003805 LEVEL ONE CMF KLS-Martin L.P. JEY 2016-03-24 00888118003935 LEVEL ONE NEURO KLS-Martin L.P. JEY 2016-03-24 00888118003942 LEVEL ONE CMF KLS-Martin L.P. JEY 2016-03-24 00888118003959 LEVEL ONE CMF KLS-Martin L.P. JEY 2016-03-24
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