Intra Oral Sensor IOX2

GUDID 08809460309867

Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by detecting subject information through X-rays.

Dentium Co., Ltd

Dental digital imaging sensor, intraoral
Primary Device ID08809460309867
NIH Device Record Key6473846e-18eb-417e-96db-17c2b318671f
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntra Oral Sensor
Version Model NumberIOX2
Catalog NumberIOX2
Company DUNS695504638
Company NameDentium Co., Ltd
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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+821064769603
Emailyrna@dentium.com
Phone+821064769603
Emailyrna@dentium.com
Phone+821064769603
Emailyrna@dentium.com
Phone+821064769603
Emailyrna@dentium.com
Phone+821064769603
Emailyrna@dentium.com
Phone+821064769603
Emailyrna@dentium.com
Phone+821064769603
Emailyrna@dentium.com
Phone+821064769603
Emailyrna@dentium.com
Phone+821064769603
Emailyrna@dentium.com
Phone+821064769603
Emailyrna@dentium.com
Phone+821064769603
Emailyrna@dentium.com
Phone+821064769603
Emailyrna@dentium.com
Phone+821064769603
Emailyrna@dentium.com
Phone+821064769603
Emailyrna@dentium.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108809460309867 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-14
Device Publish Date2020-08-06

On-Brand Devices [Intra Oral Sensor]

08809460309867Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by det
08809460309850Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by det

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