I-View Gold IS015-S

GUDID 08055060430290

Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure

TRIDENT SRL

Dental digital imaging sensor, intraoral
Primary Device ID08055060430290
NIH Device Record Key6f451ecb-423c-46e5-b8cc-6ea22e74139e
Commercial Distribution StatusIn Commercial Distribution
Brand NameI-View Gold
Version Model Numbersize 2
Catalog NumberIS015-S
Company DUNS430142798
Company NameTRIDENT SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone(904) 477-3203
Emailjoyce510kfda@gmail.com
Phone4073191348
Emailmarcelo.funk@trident-dental.com
Phone4073191348
Emailmarcelo.funk@trident-dental.com
Phone4073191348
Emailmarcelo.funk@trident-dental.com
Phone4073191348
Emailmarcelo.funk@trident-dental.com
Phone4073191348
Emailmarcelo.funk@trident-dental.com
Phone4073191348
Emailmarcelo.funk@trident-dental.com
Phone4073191348
Emailmarcelo.funk@trident-dental.com
Phone4073191348
Emailmarcelo.funk@trident-dental.com
Phone4073191348
Emailmarcelo.funk@trident-dental.com
Phone4073191348
Emailmarcelo.funk@trident-dental.com
Phone4073191348
Emailmarcelo.funk@trident-dental.com

Device Dimensions

Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter
Width31.3 Millimeter
Length42.9 Millimeter
Height4.8 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108055060430290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem, X-Ray, Extraoral Source, Digital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-14
Device Publish Date2020-07-06

On-Brand Devices [I-View Gold]

08055060430290Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure
08055060430283Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure

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