PB Uni tibial trial component

GUDID 04048844541422

implantcast GmbH

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Primary Device ID	04048844541422
NIH Device Record Key	3ebebba3-9e54-456a-9871-a0e518352c17
Commercial Distribution Status	In Commercial Distribution
Brand Name	PB Uni tibial trial component
Version Model Number	40120015
Company DUNS	324369826
Company Name	implantcast GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04048844541422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K203341

FDA Product Code

HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer