FDA.reportPublic FDA data

NA

Primary DI
10886705026180
Brand
NA
Company
Medos International Sàrl
Model
242300
Catalog number
242300
Device description
OVB1 HD Camera Control Unit Contents also include: (1) Power Cable, (1) USB Flash Drive, (1) Video Cable DVI-D to DVI-D, 1m, (1) Video Cable DVI-D to DVI-D, 3m, (1) Video Cable HD SDI, 12 ft, (2) Remote Cable, 3.5mm, 3 ft
Published
2016-01-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWFCAMERA, TELEVISION, ENDOSCOPIC, WITHOUT AUDIO

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWFCamera, Television, Endoscopic, Without AudioGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705026180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670502618010886705026180

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitAn electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius60 Degrees Celsius
Handling Environment Temperature14 Degrees Fahrenheit140 Degrees Fahrenheit
Special Storage Condition, Specify00Waste Electrical and Electronic Equipment
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature14 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034579689N/A6983451876983451872026-09-26
10705034579696N/A6983451886983451882026-09-26
10705034579702N/A6983451896983451892026-09-26
10705034581835ROBOTIC INTEGRATION INSTRUMENTS2914-89-0012914890012025-04-17
10705034581842ROBOTIC INTEGRATION INSTRUMENTS2914-89-0022914890022025-04-17
10705034602349ROBOTIC INTEGRATION INSTRUMENTS2914-89-4032914894032025-04-17
10705034602424ROBOTIC INTEGRATION INSTRUMENTS2914-89-4012914894012025-04-17
10705034602462ROBOTIC INTEGRATION INSTRUMENTS2914-89-0002914890002025-04-17
10705034643243VELYS4516110384516110382025-03-28
10705034643250VELYS4516110504516110502025-03-28
10705034643274VELYS4516110214516110212025-03-28
10705034643281VELYS4516110554516110552025-03-28
10705034643298VELYS4516110474516110472025-03-28
10705034643304VELYS4516110464516110462025-03-28
10705034643328VELYS4516110404516110402025-03-28
10705034643342VELYS4516110624516110622025-03-28
10705034643359VELYS4516110454516110452025-03-28
10705034643366VELYS4516110444516110442025-03-28
10705034643373VELYS4516110434516110432025-03-28
10705034643380VELYS4516110414516110412025-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840319757987Hayden MedicalHayden Medical, Inc.FWF2026-04-23
00840319758984Hayden MedicalHayden Medical, Inc.FWF2026-04-22
00840319758991Hayden MedicalHayden Medical, Inc.FWF2026-04-22
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
08051887043286THD DIGITAL MINICAMTHD SPAFWF2025-02-20
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
04250337100317C-Camsource®Joimax GmbHFWF2022-12-30
04250337100324C-Camsource®Joimax GmbHFWF2022-12-30
04250337100331C-Camsource®Joimax GmbHFWF2022-12-30
04250337100348C-Camsource®Joimax GmbHFWF2022-12-30
04250337100362D-Camsource®Joimax GmbHFWF2022-12-30