Home GUDID M384CF260400030 CranioFit
Primary DI M384CF260400030
Brand CranioFit
Company Bioplate, Inc.
Model KT-T4L3H1
Catalog number CF26040003
Device description CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
Published 2024-10-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
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 M384CF260400030 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Cranioplasty plate, non-alterable An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 838734093 Device count 1 Lot or batch true Manufacturing date on label 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 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 00810077249024 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2023-01-12 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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