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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
PWD30+SF XS12 K3 FDA UDI
Model / Reference
ARD568414512A FDA UDI
Description
PWD30+SF XS12 K3 FDA UDI

Identifiers

Primary DI / UDI-DI
03700712403751 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 field of light designed to provide a specialized source of illumination for medical intervention. It features an individual light head with multiple light sources, including halogen bulbs or LEDs, reflectors, mirrors, and a focus adjustment mechanism. Typically mounted to the ceiling or wall of an operating room (OR), this device is often part of an OR light system and can be used in various 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 a691e594-8406-4cd6-afd7-0a0165747d0e 35 fields · synced Jul 7, 2026