PB Uni tibial trial insert

GUDID 04048844030995

implantcast GmbH

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Primary Device ID	04048844030995
NIH Device Record Key	c3bfee99-1f1e-49d8-bbb6-49dc99baa28a
Commercial Distribution Status	In Commercial Distribution
Brand Name	PB Uni tibial trial insert
Version Model Number	40120210
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	04048844030995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K203341

FDA Product Code

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