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Powerled Tm

FDA UDI

Class II (US FDA UDI)

by Maquet, Inc.

Identity

Trade Name
POWERLED TM FDA UDI
Generic Name
Operating room light FDA UDI
Device Name
PWD55+DF HOR HD K3 FDA UDI
Model / Reference
ARDPWD229031A FDA UDI
Description
PWD55+DF HOR HD K3 FDA UDI

Identifiers

Primary DI / UDI-DI
03700712402860 FDA UDI
510(k) Number
K070442 FDA UDI
FDA Product Code
FSY FDA UDI
GMDN Term
Operating room light FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4580 FDA UDI
Commercial Distribution
Not 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
MRI Safety
MR Unsafe FDA UDI

POWERLED TM is a high-intensity, high-color-rendering light source designed to provide a specialized source of illumination for medical interventions in operating rooms (ORs). This device features an individual light head with multiple light sources, including halogen bulbs or LEDs, reflectors, mirrors, and a focus adjustment mechanism. It is typically mounted to the ceiling or wall of an OR and can be part of an OR light system. With a high-intensity design and advanced optics, POWERLED TM minimizes shadows and heat emission, making it ideal for surgical procedures.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Maquet, Inc.

Sources (1)

  • FDA UDI b19f1027-9466-4b87-ab05-9b0269d7e4db 35 fields · synced Jul 6, 2026