← Back to catalogue

Luminelle DTx Control Hub

FDA UDI

Class II (US FDA UDI)

by Uvision360, Inc.

Identity

Trade Name
Luminelle DTx Control Hub FDA UDI
Generic Name
Flexible video cystoscope, reusable FDA UDI
Model / Reference
20012 FDA UDI

Identifiers

Primary DI / UDI-DI
00853277008039 FDA UDI
510(k) Number
K181909 FDA UDI
FDA Product Code
HIH FDA UDI
FAJ FDA UDI
GMDN Term
Flexible video cystoscope, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1690 FDA UDI
876.1500 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Flexible video cystoscope, reusableFlexible fibreoptic hysteroscope

Luminelle DTx Control Hub by Uvision360, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible fibreoptic hysteroscope.

Cleared under the same submission

K181909 also covers:

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
Uvision360, Inc.

Sources (1)

  • FDA UDI 421f6ce6-30f6-461e-84e7-2ca14c3f0b72 33 fields · synced May 30, 2026