MyPAO Planning report

GUDID 07630971243378

MyPAO Planning report

Medacta International SA

Orthopaedic/craniofacial implantation planning software
Primary Device ID07630971243378
NIH Device Record Key65c7d536-cbab-4cce-bbc3-7556c33722ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyPAO Planning report
Version Model Number05.07.001SWO
Company DUNS488227125
Company NameMedacta International SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107630971243378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-02
Device Publish Date2021-02-22

Devices Manufactured by Medacta International SA

07630345734525 - Mpact 3D Metal2026-02-10 Mpact 3D metal Shell Multi Hole Thin Ø44mm
07630345752857 - Mpact 3D Metal2026-02-10 Mpact 3D metal Shell Two Hole Ø44mm
07630542743931 - Mpact 3D Metal2026-02-10 Mpact 3D metal Shell Two-Hole Ø42 T
07630542743948 - Mpact 3D Metal2026-02-10 Mpact 3D metal Shell Two-Hole Ø44 T
07630542743955 - Mpact 3D Metal2026-02-10 Mpact 3D metal Shell Two-Hole Ø46 T
07630542743962 - Mpact 3D Metal2026-02-10 Mpact 3D metal Shell Two-Hole Ø48 T
07630542743979 - Mpact 3D Metal2026-02-10 Mpact 3D metal Shell Two-Hole Ø50 T
07630542743986 - Mpact 3D Metal2026-02-10 Mpact 3D metal Shell Two-Hole Ø52 T

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