FDA.report

Maquet PowerLED II

Primary DI
03700712409708
Brand
Maquet PowerLED II
Company
MAQUET SAS
Model
ARDPWT259153A
Device description
PWDII50DF VP AIM MHS021 K3 1011
Published
2022-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FSYLight, Surgical, Ceiling Mounted
FTDLamp, surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2
FTDLamp, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03700712409708PrimaryGS10

GMDN Terms

TermDefinition
Operating room lightA device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius60 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
264700139
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
03700712434526Maquet PowerLED IIARDPWT679119A2025-09-03
03700712435851Maquet PowerLED IIARDPWT679120A2025-09-03
03700712436063Maquet PowerLED IIARDPWT629160A2025-09-03
03700712436087Maquet PowerLED IIARDPWT609167A2025-09-03
03700712434540VolistaARDVCS629000A2025-06-05
03700712434557VolistaARDVCS629001A2025-06-05
03700712434564VolistaARDVCS629002A2025-06-05
03700712434571VolistaARDVCS629003A2025-06-05
03700712434588VolistaARDVCS629004A2025-06-05
03700712434595VolistaARDVCS629005A2025-06-05
03700712434601VolistaARDVCS629006A2025-06-05
03700712434618VolistaARDVCS629007A2025-06-05
03700712434625VolistaARDVCS629008A2025-06-05
03700712434632VolistaARDVCS629009A2025-06-05
03700712434649VolistaARDVCS629071A2025-06-05
03700712434656VolistaARDVCS629072A2025-06-05
03700712434663VolistaARDVCS629073A2025-06-05
03700712434670VolistaARDVCS629074A2025-06-05
03700712434687VolistaARDVCS629077A2025-06-05
03700712434694VolistaARDVCS629078A2025-06-05

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B510SL700700LED1ADVANCED SURGICAL LAMP ADVANCED INSTRUMENTATIONS, INC.FSY2026-03-24
20192253051985DevonCardinal Health 200, LLCFSY2026-03-11
00850053798016APEX LEDBurton Medical, LLCFSY2026-02-19
00684706009682iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009699iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009705iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009712iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009729iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009736iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009743iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009750iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
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00684706009774iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009781iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009798iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009811iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009828iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00724995243593ALYONSTERIS CORPORATIONFSY2026-01-05
03700712434526Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712435851Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436063Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436087Maquet PowerLED IIMAQUET SASFTD2025-09-03
00850036790020AliteRevelle Aesthetics, Inc.FTD2025-09-01
00816744027230Myriad-LXNICO CORPORATIONFTD2025-08-11
00684706009675iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-25
00684706009644iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-24
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00684706009330iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
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