Home GUDID 00888118128508 LEVEL ONE CMF, STERILE
Primary DI 00888118128508
Brand LEVEL ONE CMF, STERILE
Company KLS-Martin L.P.
Model 25-197-17-71
Device description PLATE, L1 MMF FIXATION, 2.0 MM L1 MMF SCREW, CP TITANIUM
Published 2020-07-22
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 00888118128508 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 00888118128508 00888118128508 888118128508 0888118128508
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.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Regulatory Flags# DUNS number 826499238 Device count 1 Lot or batch true Expiration date on label 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
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