FDA.reportPublic FDA data

Maquet ROLITE

Primary DI
03700712411985
Brand
Maquet ROLITE
Company
MAQUET SAS
Model
ARDPWT309002A
Device description
ROL PWDII50SF B AIM CL K3
Published
2020-03-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
FSSLight, Surgical, Floor Standing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSSLight, Surgical, Floor StandingGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700712411985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700712411985037007124119853700712411985

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.

Storage And Handling#

Type, Low, High table
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 table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700712438524Maquet OrchideARD2019100012026-05-11
03700712434472Maquet OrchideARD5688039862026-05-06
03700712434489Maquet OrchideARD5692049452026-05-06
03700712432935Maquet EquipmentARDEQT639029A2023-12-15
03700712421489Maquet EquipmentARDSAT629009A2023-07-03
03700712422448Maquet EquipmentARDSAT629008A2023-07-03
03700712416829Maquet Equipment ARDSAT229007A2022-03-25
03700712401092NAARD515031140A2016-09-12
03700712401108NAARD515032140A2016-09-12
03700712435868Maquet EzeaARDEZA209012A2025-10-09
03700712438463VolistaARDVCS629116A2025-10-09
03700712438470VolistaARDVST629119A2025-10-09
03700712415969Maquet OrchideARD5688039512024-08-26
03700712418274Maquet OrchideARD5688039672022-03-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00855373008036NICO Myriad-LXSUNOPTIC TECHNOLOGIES LLCFSS2025-06-03
00855373008043NICO Corporation SUNOPTIC TECHNOLOGIES LLCFSS2025-06-03
M678NN70640NICO Myriad-LXSUNOPTIC TECHNOLOGIES LLCFSS2025-03-27
M678NN90100NICOSUNOPTIC TECHNOLOGIES LLCFSS2025-03-27
10686864056819Medicom SafeMaskAMD Medicom IncFSS2025-01-23
20686864056816Medicom SafeMaskAMD Medicom IncFSS2025-01-23
03700712412029Maquet RoliteMAQUET SASFSS2024-11-07
04250613849282DM MS Sim.LED ExL DES.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849305MS Sim.LED OpL wSBS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849329MS Sim.LED OpL wDBS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849367MS Sim.LED OpL USS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849404DM MS Sim.LED ExL wSBS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
03700712432508Maquet RoliteMAQUET SASFSS2024-06-20
03700712432522Maquet RoliteMAQUET SASFSS2024-06-20
03700712432515Maquet RoliteMAQUET SASFSS2024-02-02
14026704741837PILLINGTELEFLEX INCORPORATEDFSS2024-01-16
24026704741834PILLINGTELEFLEX INCORPORATEDFSS2024-01-16
03700712432539Maquet RoliteMAQUET SASFSS2023-12-15
03700712422745Maquet RoliteMAQUET SASFSS2023-09-19
03700712422752Maquet RoliteMAQUET SASFSS2023-09-19
03700712422769Maquet RoliteMAQUET SASFSS2023-09-19
03700712422776Maquet RoliteMAQUET SASFSS2023-09-19
03700712422783Maquet RoliteMAQUET SASFSS2023-09-19
03700712422790Maquet RoliteMAQUET SASFSS2023-09-19
03700712422806Maquet RoliteMAQUET SASFSS2023-09-19
03700712422813Maquet RoliteMAQUET SASFSS2023-09-19
03700712422820Maquet RoliteMAQUET SASFSS2023-09-19
03700712422837Maquet RoliteMAQUET SASFSS2023-09-19
03700712422844Maquet RoliteMAQUET SASFSS2023-09-19
03700712422851Maquet RoliteMAQUET SASFSS2023-09-19