Home GUDID M3848135181 Bioplate@
Primary DI M3848135181
Brand Bioplate@
Company Bioplate, Inc
Model 81-3518
Catalog number 81-3518
Device description Zip® Implant - 20 mm (STERILE) [6 PK]
Published 2015-12-03
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile 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 M3848135181 Package HIBCC 6 Not in Commercial Distribution M3848135180 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.
Regulatory Flags# DUNS number 838734093 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true 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 00810188325044 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-08-03 00810188325181 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-08-03 00810188325204 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-08-03 00810188325174 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-31 00810188325129 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-28 00810188325105 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-27 00810188325099 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-23 00810188325112 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-23 00810188325068 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-20 00810188325075 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-20 00810188325082 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-20 00810188325051 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-17 00810188324955 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-14 00810188325013 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-14 00810188324795 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-13 00810188324948 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-13 00810188324986 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-13 00810188324931 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-10 00810188324979 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-10 00810188324924 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-09 00810188324702 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-07 00810188324917 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-07-06 00810188324818 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-06-26 00810188324849 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-06-26 00810188324856 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-06-26 00810188324672 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-06-22 00810188324757 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-06-22 00810188324788 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-06-22 00810188324177 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-06-09 00810188324719 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-06-09