Uni FB tibial component LM/RL

GUDID 04048844205379

implantcast GmbH

Uncoated unicondylar knee tibia prosthesis, metallic
Primary Device ID04048844205379
NIH Device Record Key9dd822db-1981-426d-8505-e834360b4412
Commercial Distribution StatusIn Commercial Distribution
Brand NameUni FB tibial component LM/RL
Version Model Number40100022
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
GS104048844205379 [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 LM/RL]

0404884448007340100027
0404884448006640100026
0404884448005940100020
0404884420539340100024
0404884420538640100023
0404884420537940100022
0404884420536240100021

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