Home GUDID 00888118145833 IPS
Primary DI 00888118145833
Brand IPS
Company KLS-Martin L.P.
Model 60-011-15-09-LP
Device description IMPLANT, PREPROSTHETIC, SUPPLEMENTAL, REMOVABLE MUA, LP, CAN, TI-6AL-4V
Published 2026-10-01
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name ELE IMPLANT, SUBPERIOSTEAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ELE Implant, Subperiosteal Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00888118145833 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 00888118145833 00888118145833 888118145833 0888118145833
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 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00888118150288 LEVEL ONE CMF, STERILE 50-280-00-71 2026-10-21 00888118150295 LEVEL ONE CMF, STERILE 50-280-03-71 2026-10-21 00888118150301 LEVEL ONE CMF, STERILE 50-280-05-71 2026-10-21 00888118150318 LEVEL ONE CMF, STERILE 50-280-07-71 2026-10-21 00888118150325 LEVEL ONE CMF, STERILE 50-280-09-71 2026-10-21 00888118150332 LEVEL ONE CMF, STERILE 50-280-11-71 2026-10-21 00888118150349 LEVEL ONE CMF, STERILE 50-282-00-71 2026-10-21 00888118150356 LEVEL ONE CMF, STERILE 50-282-03-71 2026-10-21 00888118150363 LEVEL ONE CMF, STERILE 50-282-05-71 2026-10-21 00888118150370 LEVEL ONE CMF, STERILE 50-282-07-71 2026-10-21 00888118150387 LEVEL ONE CMF, STERILE 50-282-09-71 2026-10-21 00888118150394 LEVEL ONE CMF, STERILE 50-282-11-71 2026-10-21 00888118150400 LEVEL ONE CMF, STERILE 50-302-09-71 2026-10-21 00888118150417 LEVEL ONE CMF, STERILE 50-302-11-71 2026-10-21 00888118154910 LEVEL ONE CMF 25-874-11-61 2026-10-21 00888118154927 LEVEL ONE CMF 25-874-11-91 2026-10-21 00888118154934 LEVEL ONE CMF 25-874-15-91 2026-10-21 00888118154941 LEVEL ONE CMF 25-874-15-61 2026-10-21 00888118154958 LEVEL ONE CMF, STERILE 25-874-11-71 2026-10-21 00888118154965 LEVEL ONE CMF, STERILE 25-874-15-71 2026-10-21
Other Devices Sharing Product Codes# 
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