MUTARS® trial femoral stem

GUDID 04048844064983

implantcast GmbH

General internal orthopaedic fixation system implantation kit
Primary Device ID04048844064983
NIH Device Record Key63a24c4c-6bdb-4bcc-a449-b7ee326db3e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMUTARS® trial femoral stem
Version Model Number77600013
Company DUNS324369826
Company Nameimplantcast GmbH
Device Count1
DM Exempttrue
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

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104048844064983 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04048844064983]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-09
Device Publish Date2019-04-01

On-Brand Devices [MUTARS® trial femoral stem]

0404884406500377600017
0404884406499077600015
0404884406498377600013
0404884406497677600011

Trademark Results [MUTARS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MUTARS
MUTARS
79189818 5135143 Live/Registered
implantcast GmbH
2016-05-17

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