DEXIS Platinum™ intraoral sensor PLU5101S

GUDID EKAV082250710

Digital intraoral sensor

DEXIS LLC

Dental digital imaging sensor, intraoral
Primary Device IDEKAV082250710
NIH Device Record Key673da74a-63fe-4b60-92a4-50c0e9e2c222
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEXIS Platinum™ intraoral sensor
Version Model Number0.822.5071
Catalog NumberPLU5101S
Company DUNS019717844
Company NameDEXIS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com
Phone+18888833947
Emailsupport@dexis.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEKAV082250710 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [DEXIS Platinum™ intraoral sensor]

EKAV101184190Digital intraoral sensor
EKAV101184180Digital intraoral sensor
EKAV101184170Digital intraoral sensor
EKAV100898770Digital intraoral sensor
EKAV100898740Digital intraoral sensor
EKAV100730420Digital intraoral sensor
EKAV082251940Digital intraoral sensor
EKAV082250740Digital intraoral sensor
EKAV082250730Digital intraoral sensor
EKAV082250710Digital intraoral sensor

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