← Back to catalogue

Ilumien™

FDA UDI

Class II (US FDA UDI)

by Lightlab Imaging, Inc.

Identity

Trade Name
Ilumien™ FDA UDI
Generic Name
Coronary optical coherence tomography system FDA UDI
Model / Reference
D.2 Software FDA UDI

Identifiers

Catalog Number
C408660 FDA UDI
Primary DI / UDI-DI
00812059021338 FDA UDI
FDA Product Code
NQQ FDA UDI
DQO FDA UDI
GMDN Term
Coronary optical coherence tomography system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
870.1200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Coronary optical coherence tomography system

Ilumien™ 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Lightlab Imaging, Inc.

Sources (1)

  • FDA UDI 93d536e5-2459-4c57-b0d6-ac0483049824 35 fields · synced May 31, 2026