FDA.reportPublic FDA data

LUCEA LED ®

Primary DI
03700712405335
Brand
LUCEA LED ®
Company
MAQUET SAS
Model
ARD568604955
Device description
POWER SUPPLY LCA 2 W
Published
2016-11-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NTNLed light source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTNLed Light SourceGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700712405335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700712405335037007124053353700712405335

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
264700139
Device count
1
DM exempt
false
Premarket exempt
false
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 DI, Brand, Model table
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

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Primary DI, Brand, Company table
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04250480100349NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
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04250480101735NASCHÖLLY FIBEROPTIC GmbHNTN2024-12-03
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04953170454141VISERA S VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NTN2024-11-14
00840183528522BR Surgical, LLCBR Surgical, LLCNTN2024-10-25
00840183528539BR Surgical, LLCBR Surgical, LLCNTN2024-10-25
00840183500474BR Surgical, LLCBR Surgical, LLCNTN2024-07-23
00857556008567BR Surgical, LLCBR Surgical, LLCNTN2024-07-23
00840183500023BR Surgical, LLCBR Surgical, LLCNTN2024-07-22
00840183500047BR Surgical, LLCBR Surgical, LLCNTN2024-07-22
06973031299894WhtNavi Light SourceGuangdong Optomedic Technologies, Inc.NTN2024-03-26
08033638801055Pen LEDSAPI MED SPANTN2023-08-02
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04250369706785ILOILO electronic GmbHNTN2023-06-22
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06971381250114LED Light SourceSCIVITA MEDICAL TECHNOLOGY CO., LTD.NTN2023-05-17
04049047657545NAGimmi GmbHNTN2023-05-03