PB Uni tibial trial insert

GUDID 04048844504267

implantcast GmbH

Knee tibia prosthesis trial
Primary Device ID04048844504267
NIH Device Record Key327956bd-b8c8-48ff-8e70-38c4d9f92288
Commercial Distribution StatusIn Commercial Distribution
Brand NamePB Uni tibial trial insert
Version Model Number40120412
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
GS104048844504267 [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

[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

Moist Heat or Steam Sterilization


[04048844504267]

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 insert]

0404884450426740120412
0404884450425040120312
0404884450424340120212
0404884450423640120112
0404884450349940120414
0404884450348240120314
0404884450347540120214
0404884450346840120114
0404884450345140120914
0404884450343740120912
0404884450342040120911
0404884450341340120910
0404884450340640120909
0404884450337640120908
0404884403108440120411
0404884403107740120410
0404884403106040120409
0404884403105340120408
0404884403104640120311
0404884403103940120310
0404884403102240120309
0404884403101540120308
0404884403100840120211
0404884403099540120210
0404884403098840120209
0404884403097140120208
0404884403096440120111
0404884403095740120110
0404884403094040120109
0404884403093340120108

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