FDA.reportPublic FDA data

Maquet Equipment

Primary DI
03700712422387
Brand
Maquet Equipment
Company
MAQUET SAS
Model
ARDEQT639026A
Device description
EQTXHD127 SAX08
Published
2023-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
FXRHOLDER, CAMERA, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXRHolder, Camera, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700712422387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700712422387037007124223873700712422387

GMDN Terms#

Term, Definition table
TermDefinition
Medical monitor/light mountA permanently-fixed structure 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]. The mount is intended to be permanently-fixed to the ceiling and/or wall. This device will be designed to enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device to be mounted (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
00888867514263Arthrex®ARTHREX, INC.FXR2026-01-26
03700712414283Maquet EquipmentMAQUET SASFXR2025-01-06
03700712414290Maquet EquipmentMAQUET SASFXR2025-01-06
03700712414306Maquet EquipmentMAQUET SASFXR2025-01-06
03700712421403Maquet EquipmentMAQUET SASFXR2024-03-05
03700712422455Maquet EquipmentMAQUET SASFXR2024-03-05
03700712422462Maquet EquipmentMAQUET SASFXR2024-03-05
03700712432935Maquet EquipmentMAQUET SASFXR2023-12-15
03700712421410Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421427Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421434Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421441Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421458Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421465Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421472Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421489Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421496Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422240Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422257Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422264Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422271Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422288Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422295Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422301Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422318Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422325Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422332Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422349Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422356Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422363Maquet EquipmentMAQUET SASFXR2023-07-03