EDLENi Dental Sensor - Size 1

GUDID 00862973000346

EDLENi Dental Sensor, CMOS Image Sensor, CsI Scintillator, 2.5 meter cable

EDLEN IMAGING, LLC

Dental digital imaging sensor, intraoral
Primary Device ID00862973000346
NIH Device Record Key12d19d21-0ca4-46c7-92f3-25ec33cc5dc7
Commercial Distribution StatusIn Commercial Distribution
Brand NameEDLENi Dental Sensor - Size 1
Version Model NumberS11684-16-43
Company DUNS078801340
Company NameEDLEN IMAGING, LLC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone480-659-8430
Emailnick@edlenimaging.com

Device Dimensions

Width25 Millimeter
Width25 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100862973000346 [Primary]

FDA Product Code

MUHSystem,X-Ray,Extraoral Source,Digital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-10-09

Devices Manufactured by EDLEN IMAGING, LLC

00862973000346 - EDLENi Dental Sensor - Size 12018-03-29EDLENi Dental Sensor, CMOS Image Sensor, CsI Scintillator, 2.5 meter cable
00862973000346 - EDLENi Dental Sensor - Size 12018-03-29 EDLENi Dental Sensor, CMOS Image Sensor, CsI Scintillator, 2.5 meter cable
00862973000353 - EDLENi Dental Sensor - Size 22018-03-29 EDLENi Dental Sensor, CMOS image sensor, CsI Scintillator, 2.5 meter cable

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