Home GUDID H9804600020 NA
Primary DI H9804600020
Brand NA
Company SYNTHES (U.S.A.) LP
Model 460.002
Catalog number 460002
Device description TI CRANIAL FLAP TUBE CLAMP 18MM DIA
Published 2015-09-14
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 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 10887587054766 Primary GS1 0 H9804600020 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10887587054766 10887587054766
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 832637081 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810188324665 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-06-01 00810188324641 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-05-28 00810188324658 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-05-28 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 00810077248829 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2023-01-16 00810077248836 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2023-01-16 00810077248973 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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