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Dragonfly OpStar™

FDA UDI

Class II (US FDA UDI)

by Lightlab Imaging, Inc.

Identity

Trade Name
Dragonfly OpStar™ FDA UDI
Generic Name
Coronary optical coherence tomography system catheter FDA UDI
Device Name
Imaging Catheter FDA UDI
Model / Reference
1014651 FDA UDI
Description
Imaging Catheter FDA UDI

Identifiers

Catalog Number
1014651 FDA UDI
Primary DI / UDI-DI
05415067031129 FDA UDI
FDA Product Code
DQO FDA UDI
GMDN Term
Coronary optical coherence tomography system catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Coronary optical coherence tomography system catheter

Dragonfly OpStar™ by Lightlab Imaging, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coronary optical coherence tomography system catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lightlab Imaging, Inc.

Sources (1)

  • FDA UDI f09c176a-0dfe-4a8f-aaa7-8957fc8f72b7 36 fields · synced May 31, 2026