Uni FB tibial component LL/RM

GUDID 04048844205348

implantcast GmbH

Uncoated unicondylar knee tibia prosthesis, metallic
Primary Device ID04048844205348
NIH Device Record Keyc77d59c1-92f1-4369-977c-826c96e956db
Commercial Distribution StatusIn Commercial Distribution
Brand NameUni FB tibial component LL/RM
Version Model Number40100013
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS104048844205348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-20
Device Publish Date2021-01-12

On-Brand Devices [Uni FB tibial component LL/RM]

0404884448010340100017
0404884448009740100016
0404884448008040100010
0404884420535540100014
0404884420534840100013
0404884420533140100012
0404884420532440100011

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