242300

GUDID 10886705026180

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

Medos International Sàrl

Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit
Primary Device ID10886705026180
NIH Device Record Key877a89ea-b0d3-44e0-9963-91134c40bcb1
Commercial Distribution StatusIn Commercial Distribution
Version Model Number242300
Catalog Number242300
Company DUNS482661753
Company NameMedos International Sàrl
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Operating and Storage Conditions

Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Waste Electrical and Electronic Equipment
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110886705026180 [Primary]
GS110886705026180 [Primary]
GS110886705026180 [Primary]

FDA Product Code

FWFCAMERA, TELEVISION, ENDOSCOPIC, WITHOUT AUDIO
FWFCAMERA, TELEVISION, ENDOSCOPIC, WITHOUT AUDIO
FWFCAMERA, TELEVISION, ENDOSCOPIC, WITHOUT AUDIO

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-19
Device Publish Date2016-01-30

Devices Manufactured by Medos International Sàrl

10886705026180 - NA2020-05-19OVB1 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
10886705026180 - NA2020-05-19 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)
10886704075431 - CERELINK2020-05-06 CERELINK ICP SENSOR Metal Skull Bolt Kit For Intraparenchymal Procedure
10886704075448 - CERELINK2020-05-06 CERELINK ICP SENSOR Basic Kit for Subdural/Intraparenchymal Procedure
10886704075455 - CERELINK2020-05-06 CERELINK ICP SENSOR Plastic Skull Bolt Kit For Intraparenchymal Procedure
10886704075462 - CERELINK2020-05-06 CERELINK ICP SENSOR Ventricular Catheter Kit with ICP Sensor
10886704075707 - NA2020-05-06 Patient Monitor Interface Cable - Spacelabs (6 Pin)
10886704075738 - NA2020-05-06 Patient Monitor Interface Cable - GE Datex-Ohmeda (11 Pin)
10886704078661 - DIRECTLINK2020-05-06 DirectLink ICP Module

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