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C7 Dragonfly™

FDA UDI

Class II (US FDA UDI)

by Lightlab Imaging, Inc.

Identity

Trade Name
C7 Dragonfly™ FDA UDI
Generic Name
Coronary optical coherence tomography system catheter FDA UDI
Device Name
Imaging Catheter FDA UDI
Model / Reference
100-100-00 FDA UDI
Description
Imaging Catheter FDA UDI

Identifiers

Catalog Number
100-100-00 FDA UDI
Primary DI / UDI-DI
00183739000562 FDA UDI
FDA Product Code
ORD 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

Yes

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 2.7 French FDA UDI

Category: Coronary optical coherence tomography system catheter

C7 Dragonfly™ 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 1406c2b6-29a9-4471-a9ff-24131e153c60 37 fields · synced May 30, 2026