Home GUDID 00888118131270 LEVEL ONE CMF, STERILE
Primary DI 00888118131270
Brand LEVEL ONE CMF, STERILE
Company KLS-Martin L.P.
Model 50-174-04-75
Device description SCREW, MAXDRIVE, TLTS, FASTENING, TEMPORARY CONDYLAR IMPLANT, TI-6AL-4V
Published 2021-11-22
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
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 10888118131277 Primary GS1 0 00888118131270 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10888118131277 10888118131277 00888118131270 00888118131270 888118131270 0888118131270
GMDN Terms# Term, Definition table Term Definition Temporary mandibular condyle prosthesis A sterile implantable device intended for the temporary reconstruction of the mandibular condyle of the temporomandibular joint (TMJ) typically in a patient undergoing ablative surgery requiring the removal of the mandibular condyle. It is typically made of metal or synthetic material and includes the condyle head with an adjustable plate for attachment to the remaining natural mandible.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Regulatory Flags# DUNS number 826499238 Device count 5 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00888118108357 DISTRACTION, INTERNAL, STERILE 51-556-20-81 2018-09-26 00888118108364 DISTRACTION, INTERNAL, STERILE 51-557-20-81 2018-09-26 00888118147226 LEVEL ONE EXTREMITY 26-950-64-04 2026-07-21 00888118147233 LEVEL ONE EXTREMITY 26-950-65-04 2026-07-21 00888118147240 LEVEL ONE EXTREMITY 26-950-66-04 2026-07-21 00888118147257 LEVEL ONE EXTREMITY 26-950-67-04 2026-07-21 00888118147264 LEVEL ONE EXTREMITY 26-950-68-04 2026-07-21 00888118147271 LEVEL ONE EXTREMITY 26-950-69-04 2026-07-21 00888118147714 LEVEL ONE EXTREMITY 26-950-58-04 2026-07-21 00888118147721 LEVEL ONE EXTREMITY 26-950-59-04 2026-07-21 00888118147738 LEVEL ONE EXTREMITY 26-950-62-04 2026-07-21 00888118147745 LEVEL ONE EXTREMITY 26-950-63-04 2026-07-21 00888118154620 LEVEL ONE CMF 25-315-92-91 2026-07-21 00888118154637 LEVEL ONE CMF 50-743-06-09 2026-07-21 00888118154644 LEVEL ONE, STERILE 25-433-97-71 2026-07-21 00888118154651 LEVEL ONE, STERILE 25-438-97-71 2026-07-21 00888118154668 LEVEL ONE, STERILE 25-439-91-71 2026-07-21 00888118154675 LEVEL ONE, STERILE 25-486-97-71 2026-07-21 00888118154682 LEVEL ONE, STERILE 25-487-97-71 2026-07-21 00888118154699 LEVEL ONE, STERILE 50-817-15-71 2026-07-21
Other Devices Sharing Product Codes# 
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