DEXIS Titanium Sensor Kit

GUDID EKAV101329130

Imaging Sciences International

Dental digital imaging sensor, intraoral
Primary Device IDEKAV101329130
NIH Device Record Keyddc5a1c0-0937-49af-a126-373f713ced8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEXIS Titanium Sensor Kit
Version Model Number1.013.2913
Company DUNS800111106
Company NameImaging Sciences International
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEKAV101329130 [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 Date2022-01-31
Device Publish Date2022-01-21

On-Brand Devices [DEXIS Titanium Sensor Kit]

EKAV1014521001.014.5210
EKAV1014520901.014.5209
EKAV1014520701.014.5207
EKAV1013756501.013.7565
EKAV1013291301.013.2913

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.