Home GUDID 00888118094346 LEVEL ONE CMF
Primary DI 00888118094346
Brand LEVEL ONE CMF
Company KLS-Martin L.P.
Model 995-7090-01
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 MQN EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MQN External Mandibular Fixator And/Or Distractor Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00888118094346 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 00888118094346 00888118094346 888118094346 0888118094346
GMDN Terms# Term, Definition table Term Definition Craniofacial fixation plate, non-bioabsorbable A small, implantable sheet of firm material that is attached with screws to fractured craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material cannot be chemically degraded or absorbed by natural body processes [includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre]. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.
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 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 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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