FDA.reportPublic FDA data

FLUOCLIP

Primary DI
B475LXHO0
Brand
FLUOCLIP
Company
FLUOPTICS
Model
LXHO
Published
2021-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
B475LXHO0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Stationary general-purpose fluoroscopic x-ray system, digitalA stationary general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be viewed in both real-time and delayed format.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
260631677
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B475FMSA0FLUOPODFMSA2023-09-29
B475FBLXR0FLUOBEAM LX RedFBLXR2024-05-06
B475FBLM0FLUOBEAM LMFBLM2021-02-18
B475FBLX0FLUOBEAM LXFBLX2019-09-05
B475FB800CLV180FLUOBEAM 800FB800-CL v1.82017-04-27
B475FB800CLV190FLUOBEAM 800FB800-CL v1.92018-06-25
B475FC800CLV180FLUOCASE 800FC800-CL v1.82017-04-27
B475FC800CLV190FLUOCASE 800FC800-CL v1.92018-06-25
B475FKCL0FLUOCARTFK-CL2022-01-31
B475PVUEC0A1V100PHOTONVUEPVUEC0A1 V1.02017-04-27
B475PVUEC0A2V100PHOTONVUEPVUEC0A2 V1.02017-04-27
B475PVUECCB100PHOTONVUE CONTROL BOXPVUECCB-1.02018-01-19
B475PVUECOH100PHOTONVUE OPTICAL HEADPVUECOH-1.02018-01-19
B475PVUETSC101Photonvue boxPVUE-TSC-1.02018-01-19
B475FXCLV111FLUOBEAM SYSTEM STORED INTO FLUOBOXFX-CL v1.12017-04-27

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