Home GUDID 00888118095022 IPS
Primary DI 00888118095022
Brand IPS
Company KLS-Martin L.P.
Model 60-660-01-04
Device description IMPLANT, MANDIBLE, TI-6AL-4V
Published 2016-03-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name JEY PLATE, BONE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JEY Plate, Bone Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00888118095022 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 00888118095022 00888118095022 888118095022 0888118095022
GMDN Terms# Term, Definition table Term Definition Cranial bone prosthesis, custom-made A sterile 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 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label false 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 00888118149671 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149701 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149718 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149725 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149732 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149749 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149756 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149763 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149770 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149787 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149794 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149800 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149817 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149824 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149831 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149848 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149855 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149879 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149886 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149893 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149909 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149916 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149923 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149930 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149947 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149954 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149961 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149978 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149985 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118153128 LEVEL ONE NEURO, STERILE KLS-Martin L.P. JEY 2026-03-23
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