STAR PSI Standard Bundle with Anatomical Models

GUDID 00810028394971

Trilliant Surgical, LLC

Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide

Primary Device ID	00810028394971
NIH Device Record Key	db79a29b-2aef-491b-b9c9-67fa38a8fcf2
Commercial Distribution Status	In Commercial Distribution
Brand Name	STAR PSI Standard Bundle with Anatomical Models
Version Model Number	601-00-001
Company DUNS	828829072
Company Name	Trilliant Surgical, LLC
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	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810028394971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P050050

FDA Product Code

NTG	Prosthesis, Ankle, Uncemented, Non-Constrained