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Center Focus Handle

FDA UDI

Class II (US FDA UDI)

by Skytron, LLC

Identity

Trade Name
Center Focus Handle FDA UDI
Generic Name
Operating room light system FDA UDI
Device Name
Center Focus Handle with Intensity Control for Aurora II, Aurora 3, and Aurora Four Lights. FDA UDI
Model / Reference
Sterilizable Centere Focus Handle FDA UDI
Description
Center Focus Handle with Intensity Control for Aurora II, Aurora 3, and Aurora Four Lights. FDA UDI

Identifiers

Catalog Number
B1-530-10 FDA UDI
Primary DI / UDI-DI
10841736110567 FDA UDI
FDA Product Code
FTA FDA UDI
GMDN Term
Operating room light system 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Operating room light system

Center Focus Handle by Skytron, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Operating room light system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Skytron, LLC

Sources (1)

  • FDA UDI 67ef59fc-2461-493d-b1f1-6b98725805c6 34 fields · synced Jun 8, 2026