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Aurora Surgical Light Series

FDA UDI

Class II (US FDA UDI)

by Skytron, LLC

Identity

Trade Name
AURORA SURGICAL LIGHT SERIES FDA UDI
Generic Name
Transportable medical equipment stand, non-powered FDA UDI
Device Name
LED MINOR PROCEDURE LIGHT FDA UDI
Model / Reference
AURORA ASTRO FDA UDI
Description
LED MINOR PROCEDURE LIGHT FDA UDI

Identifiers

Primary DI / UDI-DI
10841736110536 FDA UDI
FDA Product Code
FSS FDA UDI
FSY FDA UDI
GMDN Term
Transportable medical equipment stand, non-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4580 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Operating room light systemTransportable medical equipment stand, non-powered

Aurora Surgical Light Series by Skytron, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transportable medical equipment stand, non-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Skytron, LLC

Sources (1)

  • FDA UDI 3c339b8c-6469-4b83-a538-62cdd217823c 34 fields · synced May 30, 2026