FDA.report

PROCAM FULL PAL

Primary DI
B366U1VI3111
Brand
PROCAM FULL PAL
Company
Ecleris
Model
R00
Catalog number
U1VI3111
Device description
PROCAM FULL PAL
Published
2022-06-30
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

Related Records

Contact Domains

Product Codes

CodeName
FWFCamera, Television, Endoscopic, Without Audio

Product Code Classifications

CodeDeviceSpecialtyClass
FWFCamera, Television, Endoscopic, Without AudioGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B366U1VI3111PrimaryHIBCC0

GMDN Terms

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

TypeLowHighCondition
Handling Environment Atmospheric Pressure70 Percent (%) Relative Humidity106 Percent (%) Relative Humidity
Handling Environment Humidity35 Degrees Celsius75 Degrees Celsius
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature30 Degrees Celsius45 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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B366AIO100BRX1PROCAM PACKRX1AIO100B2025-08-22
B366AIO100SRX1PROCAM PACK SRX1AIO100S2025-08-22
B366FE1023RX1PROCAM FLEXRX1FE102/32025-08-22
B366U1VI2512R01PROCAM HD BASICR01U1VI25122025-08-22
B366U1VI360100BRX1PROCAM PACKRX1VI360/100B2025-08-22
B366U1VI360100SRX1PROCAM PACK SRX1VI360/100S2025-08-22
B366U1VI3604RX1PROCAM HD USBRX1VI360/42025-08-22
B366U1HC120G21R06Procam HD CMOS II CONSOLER06U1HC120G212025-07-30
B366U1VI3601R04Procam HD CMOS IIR04U1VI3602025-07-30
B366U1VI3603RX2Procam HD IIRX2U1VI36032025-07-30
B366U1C200AR01MICROSCOPE ColposcopeR01U1C200A2025-07-24
B366U1C200FR02MICROSCOPE ColposcopeR02U1C200F2025-07-24
B366U1C200TR02MICROSCOPE ColposcopeR02U1C200T2025-07-24

Other Devices Sharing Product Codes

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00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FWF2025-09-25
B366U1VI2512R01PROCAM HD BASICEclerisFWF2025-08-22
00840319757994Hayden MedicalHayden Medical, Inc.FWF2025-04-30
00840319757949Hayden MedicalHayden Medical, Inc.FWF2025-04-11
00840319757956Hayden MedicalHayden Medical, Inc.FWF2025-04-11
04048551061343NAKarl Storz GmbH & Co. KGFWF2025-03-28
18051887043283THD DIGITAL MINICAMTHD SPAFWF2025-02-20
00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FWF2025-01-09
00848657077071AED ENDOPRO 3DNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FWF2025-01-08
04049197151634RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFWF2024-10-16
04049197223270RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFWF2024-09-20
04049197223287RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFWF2024-09-20
04049197401654RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFWF2024-09-20
04049197505604RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFWF2024-09-20
00848657076968ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FWF2024-07-15
00848657076920ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FWF2024-06-11
00848657076937ENDOPRO-MDTKNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FWF2024-06-11
00840319756966Hayden MedicalHayden Medical, Inc.FWF2024-04-12
04049047668640NAGimmi GmbHFWF2023-05-03
B366HC2202PROCAM EclerisFWF2023-04-04
04049047669692GimmiGimmi GmbHFWF2023-02-14
04260744830561Fibre optic cableJoimax GmbHFWF2022-12-30
04260744831865Fibre optic cableJoimax GmbHFWF2022-12-30
B366U1HC112G22 PROCAM HD BASICEclerisFWF2022-09-07
B366U1VI2512PROCAM HD BASICEclerisFWF2022-09-07
B366HC2201PROCAM EclerisFWF2022-08-03
B366U1VI2511PROCAM Basic PALEclerisFWF2022-06-30
B366HC220PROCAM SDEclerisFWF2022-06-27
B366U1HC112G21 PROCAM SDEclerisFWF2022-06-27
10845854030059NAConmed CorporationFWF2021-12-15