Home GUDID 00888118113016 LEVEL ONE CMF
Primary DI 00888118113016
Brand LEVEL ONE CMF
Company KLS-Martin L.P.
Model 50-174-03-61
Published 2018-01-26
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 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 00888118113016 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 00888118113016 00888118113016 888118113016 0888118113016
GMDN Terms# Term, Definition table Term Definition Craniofacial bone screw, non-bioabsorbable, sterile A small, sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.
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 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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