FDA.reportPublic FDA data

PROCAM 4K USB

Primary DI
B366U1VI3605
Brand
PROCAM 4K USB
Company
Ecleris
Model
RX1
Catalog number
VI360/5
Device description
USB VIDEO CAMERA
Published
2026-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWDCamera, Television, Microsurgical, Without Audio

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWDCamera, Television, Microsurgical, Without AudioGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B366U1VI3605PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical video cameraAn electro-optical device (e.g., a CCD) designed to obtain moving-picture documentation of an open surgical procedure. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity35 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
786-483-7490ytzielo@ecleris.com

Regulatory Flags#

DUNS number
043555079
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
B366LED0204R00PORTALEDR00LED020/42026-02-11
B366U1C200FR01MICROSCOPE ColposcopeR01U1C200F2024-02-13
B366U1C200TR01MICROSCOPE ColposcopeR01U1C200T2024-02-13
B366U1C200WR01MICROSCOPE ColposcopeR01U1C200W2024-02-13
B366HC200AR00MICROSCOPE ColposcopeR00HC200A2024-11-27
B366U1C200AR00MICROSCOPE ColposcopeR00U1C200A2024-11-25
B366U1C200FR00MICROSCOPE ColposcopeR00U1C200F2024-02-07
B366U1C200TR00MICROSCOPE ColposcopeR00U1C200T2024-02-07
B366U1C200WR00MICROSCOPE ColposcopeR00U1C200W2024-02-07
B366MC400MICROSTAR ColposcopeR02MC4002023-08-22
B366MC410MICROSTAR ColposcopeR00MC4102023-08-22
B366C100FHD1MICROSTAR ColposcopeR00C100FHD12023-08-18
B366SN0300140SinuscopeR00SN03001402023-08-18
B366SN0330140SinuscopeR00SN03301402023-08-18
B366SN0370140SinuscopeR00SN03701402023-08-18
B366SN0400175SinuscopeR00SN04001752023-08-18
B366SN0430175SinuscopeR00SN04301752023-08-18
B366SN0445175SinuscopeR00SN04451752023-08-18
B366SN0470175SinuscopeR00SN04701752023-08-18
B366U1C100FHD1MICROSTAR ColposcopeR00U1C100FHD12023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B366U1HC130G21Procam 4KEclerisFWD2025-12-22
B366U1VI3701Procam 4KEclerisFWD2025-12-22
B366AIO100BRX1PROCAM PACKEclerisFWD2025-08-22
B366AIO100SRX1PROCAM PACK SEclerisFWD2025-08-22
B366FE1023RX1PROCAM FLEXEclerisFWD2025-08-22
B366U1VI360100BRX1PROCAM PACKEclerisFWD2025-08-22
B366U1VI360100SRX1PROCAM PACK SEclerisFWD2025-08-22
B366U1VI3604RX1PROCAM HD USBEclerisFWD2025-08-22
B366U1HC120G21R06Procam HD CMOS II CONSOLEEclerisFWD2025-07-30
B366U1VI3601R04Procam HD CMOS IIEclerisFWD2025-07-30
B366U1VI3603RX2Procam HD IIEclerisFWD2025-07-30
00840306836602Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FWD2025-02-14
00840306836374Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FWD2025-01-27
B366U1VI3603RX1Procam HD IIEclerisFWD2024-09-25
00840306831058Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FWD2024-07-19
08436041580270OptomicOPTOMIC ESPAÑA SAFWD2024-07-17
08436041580294OptomicOPTOMIC ESPAÑA SAFWD2024-07-17
B366U1VI360Procam HD CMOS IIEclerisFWD2023-09-19
M6337055100JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M633705511B0JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M63370551410JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M6337055160JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M63370552010JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M6337055250JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M6337055300JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M633705910280JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M633705910380JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M6337059240JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M6337059243100JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07
M633705924310FF0JEDMEDJEDMED INSTRUMENT COMPANYFWD2023-02-07