Home GUDID 00888118077349 LEVEL ONE CMF
Primary DI 00888118077349
Brand LEVEL ONE CMF
Company KLS-Martin L.P.
Model 50-550-04-09
Device description MESH, TRAY, HEMI MANDIBLE, RIGHT, 2.0 MM SCREW, CP TITANIUM
Published 2016-03-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name GXN PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GXN Plate, Cranioplasty, Preformed, Non-Alterable Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00888118077349 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 00888118077349 00888118077349 888118077349 0888118077349
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
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 826499238 Device count 1 Lot or batch true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810188324634 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-05-27 08859751210556 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751210563 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751210570 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751216206 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751216312 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751216329 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751216336 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751216343 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751216411 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751216428 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751216435 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 08859751216442 METICULY Patient-specific titanium mesh implant METICULY COMPANY LIMITED GXN 2026-03-05 00810007631271 AccuShape Medcad GXN 2023-06-23 00810007631288 AccuShape Medcad GXN 2023-06-23 00810007631295 AccuShape Medcad GXN 2023-06-23 00810077249031 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2023-01-20 00810077248829 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2023-01-16 00810077248836 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2023-01-16 00810077249024 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2023-01-12 00810077248973 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2023-01-09 00810077249048 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2023-01-09 00810077248980 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2023-01-05 00810077248775 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2023-01-03 00810077248997 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2022-12-22 00810077249000 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2022-12-22 00810077248706 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2022-12-21 00810077248850 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2022-12-21 00810077248904 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2022-12-21 00810077248911 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2022-12-21
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