12mm HTR Implant System, Non-Sterile

GUDID 00812926027128

TRILLIANT SURGICAL, LTD.

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Primary Device ID	00812926027128
NIH Device Record Key	064443fb-f7a2-4e4e-b05b-da2f7ddd3a8f
Commercial Distribution Status	In Commercial Distribution
Brand Name	12mm HTR Implant System, Non-Sterile
Version Model Number	220-12-004
Company DUNS	828829072
Company Name	TRILLIANT SURGICAL, LTD.
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	true
Device Combination Product	false
Single Use	true
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	true
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00812926027128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K121008

FDA Product Code

HTY	Pin, Fixation, Smooth