Pharos HD System

GUDID 00851610007374

Light, Surgical, Accessory

LONG ISLAND TECH

Surgical video camera Surgical video camera Surgical video camera Surgical video camera
Primary Device ID00851610007374
NIH Device Record Keyd70962ea-ea47-40cf-94a6-41e927c4e4bf
Commercial Distribution StatusIn Commercial Distribution
Brand NamePharos HD System
Version Model NumberP003500
Company DUNS030256600
Company NameLONG ISLAND TECH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 86 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100851610007374 [Primary]
GS100851610007374 [Primary]
GS100851610007374 [Primary]
GS100851610007374 [Primary]

FDA Product Code

KQMCamera, Surgical And Accessories
KQMCamera, Surgical And Accessories
KQMCamera, Surgical And Accessories
KQMCamera, Surgical And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

Devices Manufactured by LONG ISLAND TECH

00851610007244 - BayPort 6-Bay Charger2020-11-10 Light & Surgical Accessory
00851610007251 - BayPort Storage Solution2020-11-10 Light, Surgical, Accessory
00851610007343 - Dover Headlight System2020-11-10 Light, Surgical, Endoscopic, Accessory
00851610007374 - Pharos HD System2020-11-10Light, Surgical, Accessory
00851610007374 - Pharos HD System2020-11-10 Light, Surgical, Accessory
00851610007350 - Bristol Headlight System2020-08-17 Light, Surgical, Accessory
00851610007367 - Daymark Headlight System2020-08-17 Light, Surgical, Accessory
00851610007091 - AtoN Keywest Headlight without Fiber Optic Cable2019-02-21 Light, Surgical, Endoscopic, Accessory
00851610007107 - Hatteras2019-02-21 Light, Surgical, Endoscopic

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