FDA.reportPublic FDA data

POWERLED TM

Primary DI
03700712401825
Brand
POWERLED TM
Company
MAQUET SAS
Model
ARDROL309011A
Device description
PWD50+ ROL K3
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
FSYLight, surgical, ceiling mounted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070442000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070442000POWERLED SURGICAL LIGHT SYSTEMMaquet S.A.2007-03-16FSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700712401825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700712401825037007124018253700712401825

GMDN Terms#

Term, Definition table
TermDefinition
Medical monitor/light standA mobile device designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. It is a mobile floor stand which may include wheels and/or articulated arms to enable dynamic positioning; the device to be supported (medical light/monitor) is not included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
264700139
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700712436124VolistaARDVCS209058A2026-07-20
03700712436131VolistaARDVCS209059A2026-07-20
03700712436148VolistaARDVCS209060A2026-07-20
03700712436155VolistaARDVCS209061A2026-07-20
03700712436162VolistaARDVCS209062A2026-07-20
03700712436179VolistaARDVCS209063A2026-07-20
03700712436186VolistaARDVCS209064A2026-07-20
03700712436193VolistaARDVCS209065A2026-07-20
03700712436209VolistaARDVCS209066A2026-07-20
03700712436216VolistaARDVCS209067A2026-07-20
03700712436223VolistaARDVCS209068A2026-07-20
03700712436230VolistaARDVCS209069A2026-07-20
03700712436247VolistaARDVCS209070A2026-07-20
03700712436254VolistaARDVCS209071A2026-07-20
03700712436261VolistaARDVCS209072A2026-07-20
03700712436278VolistaARDVCS209073A2026-07-20
03700712436285VolistaARDVCS209074A2026-07-20
03700712436292VolistaARDVCS209075A2026-07-20
03700712436308VolistaARDVCS209076A2026-07-20
03700712436315VolistaARDVCS209077A2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251339907300YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907317YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907324YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907348YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907362YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907379YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
03700712436124VolistaMAQUET SASFSY2026-07-20
03700712436131VolistaMAQUET SASFSY2026-07-20
03700712436148VolistaMAQUET SASFSY2026-07-20
03700712436155VolistaMAQUET SASFSY2026-07-20
03700712436162VolistaMAQUET SASFSY2026-07-20
03700712436179VolistaMAQUET SASFSY2026-07-20
03700712436186VolistaMAQUET SASFSY2026-07-20
03700712436193VolistaMAQUET SASFSY2026-07-20
03700712436209VolistaMAQUET SASFSY2026-07-20
03700712436216VolistaMAQUET SASFSY2026-07-20
03700712436223VolistaMAQUET SASFSY2026-07-20
03700712436230VolistaMAQUET SASFSY2026-07-20
03700712436247VolistaMAQUET SASFSY2026-07-20
03700712436254VolistaMAQUET SASFSY2026-07-20
03700712436261VolistaMAQUET SASFSY2026-07-20
03700712436278VolistaMAQUET SASFSY2026-07-20
03700712436285VolistaMAQUET SASFSY2026-07-20
03700712436292VolistaMAQUET SASFSY2026-07-20
03700712436308VolistaMAQUET SASFSY2026-07-20
03700712436315VolistaMAQUET SASFSY2026-07-20
03700712436322VolistaMAQUET SASFSY2026-07-20
03700712436339VolistaMAQUET SASFSY2026-07-20
03700712436346VolistaMAQUET SASFSY2026-07-20
03700712436353VolistaMAQUET SASFSY2026-07-20