ACS® Uni trial femoral component

GUDID 04048844487164

implantcast GmbH

Knee femur prosthesis trial
Primary Device ID04048844487164
NIH Device Record Keyd5d81e53-140e-431f-895a-17c72133373f
Commercial Distribution StatusIn Commercial Distribution
Brand NameACS® Uni trial femoral component
Version Model Number42160351
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS104048844487164 [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

[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

Moist Heat or Steam Sterilization


[04048844487164]

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 [ACS® Uni trial femoral component]

0404884448719542160354
0404884448718842160353
0404884448717142160352
0404884448716442160351

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