Home GUDID M3848135161 Bioplate@
Primary DI M3848135161
Brand Bioplate@
Company Bioplate, Inc
Model 81-3516
Catalog number 81-3516
Device description Zip® Implant - 12 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 M3848135161 Package HIBCC 6 Not in Commercial Distribution M3848135160 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 00810188325662 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-22 00810188325952 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-21 00810188325969 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-21 00810188325976 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-21 00810188325839 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-20 00810188325914 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-20 00810188325938 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-20 00810188325945 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-19 00810188325884 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-14 00810188325891 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-14 00810188325853 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-13 00810188325563 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-12 00810188325815 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-12 00810188325860 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-12 00810188325877 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-12 00810188325846 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-09 00810188325785 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-08 00810188324801 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-07 00810188325761 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-07 00810188325617 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-06 00810188325778 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-06 00810188325716 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-05 00810188325792 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-05 00810188325808 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-10-05 00810188325709 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-09-30 00810188325600 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-09-29 00810188325655 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-09-28 00810188325594 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-09-25 00810188325679 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-09-24 00810188325624 HTR-PEKK OXFORD PERFORMANCE MATERIALS, INC. GXN 2026-09-21