Home GUDID 00810188324597 HTR-PEKK
Primary DI 00810188324597
Brand HTR-PEKK
Company OXFORD PERFORMANCE MATERIALS, INC.
Model PK627328
Published 2026-05-22
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
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 00810188324597 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 00810188324597 00810188324597 810188324597 0810188324597
GMDN Terms# Term, Definition table Term Definition Custom-made cranial bone prosthesis An implantable device intended to repair a defect of the cranium or mandible that is designed and constructed with specific characteristics (e.g., size, shape, material) as prescribed by a healthcare provider for a specified patient. It is typically manufactured from a three-dimensional (3-D) model based on computed tomography (CT) images and made of plastic [e.g., ultrahigh molecular weight polyethylene (UHMWPE), polyetheretherketone (PEEK)] and/or metal [e.g., titanium (Ti)]. The device may be used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease, or for cosmetic/aesthetic purposes.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 962301359 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 true 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 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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