FDA.reportPublic FDA data

Procam HD CMOS II

Primary DI
B366U1VI360R04
Brand
Procam HD CMOS II
Company
Ecleris
Model
R04
Catalog number
U1VI360
Device description
Procam HD CMOS II
Published
2026-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
B366U1VI360R04PrimaryHIBCC0

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 Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
043555079
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B366U1VI3605PROCAM 4K USBRX1VI360/52026-05-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B366U1VI3605PROCAM 4K USBEclerisFWD2026-05-19
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
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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