Home GUDID 00810007631318 AccuPlan/AccuPlate
Primary DI 00810007631318
Brand AccuPlan/AccuPlate
Company Medcad
Model ZB-KP200
Catalog number ZB-KP200
Device description MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE
Published 2023-06-23
Public version status New
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 JEY Plate, Bone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JEY Plate, Bone Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810007631318 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 00810007631318 00810007631318 810007631318 0810007631318
GMDN Terms# Term, Definition table Term Definition Custom-made organ/bone anatomy model/surgical guide kit A collection of custom-made devices intended to be used to assist anatomical visualization, surgical treatment planning, and intraoperative surgical procedures (e.g., orientation of implant components, guiding of surgical instruments). It consists of an anatomy model(s) of an organ/bone and an orthopaedic/craniomaxillofacial surgical guide(s) [e.g., for osteotomy, arthroplasty]; it is made of synthetic polymer materials and is manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 144723868 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true 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 00888118149671 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149701 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149718 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149725 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149732 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149749 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149756 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149763 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149770 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149787 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149794 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149800 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149817 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149824 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149831 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149848 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149855 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149879 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149886 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149893 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149909 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149916 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149923 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149930 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149947 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149954 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149961 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149978 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118149985 LEVEL ONE CMF, STERILE KLS-Martin L.P. JEY 2026-03-23 00888118153128 LEVEL ONE NEURO, STERILE KLS-Martin L.P. JEY 2026-03-23
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