Home GUDID 00888118092908 DISTRACTION, INTERNAL, STERILE
Primary DI 00888118092908
Brand DISTRACTION, INTERNAL, STERILE
Company KLS-Martin L.P.
Model 51-757-40-04
Device description DIST, RESORB XG, L SHP, LEFT, COMPLETE
Published 2016-03-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name PBJ Cranial Distraction System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PBJ Cranial Distraction System Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00888118092908 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 00888118092908 00888118092908 888118092908 0888118092908
GMDN Terms# Term, Definition table Term Definition Implantable craniofacial bone distractor An implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects when gradual bone augmentation is required. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
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 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00888118149367 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2025-09-24 00888118136589 DISTRACTION, INTERNAL KLS-Martin L.P. PBJ 2023-12-25 00888118136596 DISTRACTION, INTERNAL KLS-Martin L.P. PBJ 2023-12-25 00888118136626 DISTRACTION, INTERNAL KLS-Martin L.P. PBJ 2023-12-25 00888118136633 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2023-12-25 00888118136640 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2023-12-25 00888118136657 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2023-12-25 H98004315852010 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315784010 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315788010 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315792010 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315806010 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315824050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315832050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315786050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315788050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315790050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315804050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315846050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315850050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315808050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315810050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 00842528123300 OsteoMed OSTEOMED LLC PBJ 2019-11-08 00842528123317 OsteoMed OSTEOMED LLC PBJ 2019-11-08 00888118114310 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2018-01-12 00888118114464 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2018-01-12 00888118114471 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2018-01-12 00888118114488 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2018-01-12 00888118114495 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2018-01-12 00888118114501 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2018-01-12
klsmartin.com