Identity
- Trade Name
- Dragonfly™ FDA UDI
- Generic Name
- Coronary optical coherence tomography system catheter FDA UDI
- Device Name
- Imaging Catheter FDA UDI
- Model / Reference
- Duo Kit FDA UDI
- Description
- Imaging Catheter FDA UDI
Identifiers
- Catalog Number
- C408643 FDA UDI
- Primary DI / UDI-DI
- 00183739000692 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
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.
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- Novasight Hybrid™ Catheter — Conavi Medical Inc · Class II
- Novasight Hybrid™ Catheter — Conavi Medical Inc · Class II
- Starlight Imaging Catheter — Spectrawave, Inc. · Class II
- C7 Dragonfly™ — LIGHTLAB IMAGING, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lightlab Imaging, Inc.
Sources (1)
- FDA UDI 5cd9f041-f75d-4651-ae1b-0d18542fa709 37 fields · synced Jun 7, 2026