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Veloxion

FDA UDI

Class II (US FDA UDI)

by Aulea Medical, Inc.

Identity

Trade Name
Veloxion FDA UDI
Generic Name
Resectoscope FDA UDI
Device Name
Veloxion Resectoscope FDA UDI
Model / Reference
2490 FDA UDI
Description
Veloxion Resectoscope FDA UDI

Identifiers

Catalog Number
2490 FDA UDI
Primary DI / UDI-DI
00860011104407 FDA UDI
510(k) Number
K230205 FDA UDI
FDA Product Code
FJL FDA UDI
GMDN Term
Resectoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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
Sterilization Method
Ethylene Oxide FDA UDI

Category: Resectoscope

Veloxion by Aulea Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Resectoscope.

Cleared under the same submission

K230205 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aulea Medical, Inc.

Sources (1)

  • FDA UDI 0a8b20fd-0c43-432b-957e-0b66dc0a6045 36 fields · synced May 30, 2026