Home GUDID 00888118131263 LEVEL ONE CMF
Primary DI 00888118131263
Brand LEVEL ONE CMF
Company KLS-Martin L.P.
Model 50-174-04-09
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 false
Single use true Product Codes# Code, Name table Code Name NEI Prosthesis, condyle, mandibular, temporary
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NEI Prosthesis, Condyle, Mandibular, Temporary Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10888118131260 Primary GS1 0 00888118131263 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 10888118131260 10888118131260 00888118131263 00888118131263 888118131263 0888118131263
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
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
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 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 00888118132529 LEVEL ONE EXTREMITY 26-627-12-91 2026-04-23 00888118036582 _LEVEL ONE CMF 25-043-16-09 2016-03-24 00888118048196 LEVEL ONE CMF 25-885-05-91 2016-03-24 00888118073471 LEVEL ONE CMF 50-173-01-09 2016-03-24 00888118073488 LEVEL ONE CMF 50-173-02-09 2016-03-24 00888118075581 DISTRACTION, INTERNAL 50-347-05-09 2016-03-24 00888118075604 DISTRACTION, INTERNAL 50-347-07-09 2016-03-24 00888118075611 DISTRACTION, INTERNAL 50-347-09-09 2016-03-24 00888118075635 DISTRACTION, INTERNAL 50-348-05-09 2016-03-24 00888118075659 DISTRACTION, INTERNAL 50-348-07-09 2016-03-24 00888118075666 DISTRACTION, INTERNAL 50-348-09-09 2016-03-24 00888118104007 DISTRACTION, INTERNAL, STERILE 50-347-05-71 2016-12-16 00888118104014 DISTRACTION, INTERNAL, STERILE 50-347-07-71 2016-12-16 00888118104021 DISTRACTION, INTERNAL, STERILE 50-347-09-71 2016-12-16 00888118104038 DISTRACTION, INTERNAL, STERILE 50-348-05-71 2016-12-16 00888118104045 DISTRACTION, INTERNAL, STERILE 50-348-07-71 2016-12-16 00888118104052 DISTRACTION, INTERNAL, STERILE 50-348-09-71 2016-12-16 00888118112682 LEVEL ONE CMF 25-885-05-61 2018-01-26 00888118113399 DISTRACTION, INTERNAL 50-347-05-61 2018-01-26 00888118113405 DISTRACTION, INTERNAL 50-347-07-61 2018-01-26
Other Devices Sharing Product Codes# 
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