Dragonfly OpStar™ 1014651

GUDID 05415067031129

Coronary optical coherence tomography system catheter

Primary Device ID	05415067031129
NIH Device Record Key	f09c176a-0dfe-4a8f-aaa7-8957fc8f72b7
Commercial Distribution Status	In Commercial Distribution
Brand Name	Dragonfly OpStar™
Version Model Number	1014651
Catalog Number	1014651
Company DUNS	149818952
Company Name	ST. JUDE MEDICAL, INC.
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	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight. Keep dry.

Device Issuing Agency	Device ID
GS1	05415067031129 [Primary]

DQO	CATHETER, INTRAVASCULAR, DIAGNOSTIC

Steralize Prior To Use	false
Device Is Sterile	true

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05415067051844 - Agilis™ NxT Steerable Introducer Dual-Reach™	2025-02-17 Steerable Introducer
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Mark Image Registration \| Serial	Company Trademark Application Date
DRAGONFLY OPSTAR 87780582 not registered Live/Pending	LightLab Imaging, Inc. 2018-02-01