PB Uni tibial trial component

GUDID 04048844205287

implantcast GmbH

Knee tibia prosthesis trial
Primary Device ID04048844205287
NIH Device Record Key0c3be3bf-57b9-43ae-80c5-96abbda99072
Commercial Distribution StatusIn Commercial Distribution
Brand NamePB Uni tibial trial component
Version Model Number40120021
Company DUNS324369826
Company Nameimplantcast GmbH
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS104048844205287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


[04048844205287]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-25
Device Publish Date2021-01-15

On-Brand Devices [PB Uni tibial trial component]

0404884454143940120016
0404884454142240120015
0404884454141540120010
0404884454140840120026
0404884454139240120025
0404884454138540120020
0404884420531740120024
0404884420530040120023
0404884420529440120022
0404884420528740120021
0404884420527040120014
0404884420526340120013
0404884420525640120012
0404884420524940120011

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