DEXIS Ti2 Sensor Kit

GUDID D090800025750

DEXIS Ti2 Kit, EN FR-CA

Dental Imaging Technologies Corporation

Dental digital imaging sensor, intraoral
Primary Device IDD090800025750
NIH Device Record Key36ee9684-66d9-43d5-98be-91bdb0fcac89
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEXIS Ti2 Sensor Kit
Version Model Number8.000.2575
Company DUNS800111106
Company NameDental Imaging Technologies Corporation
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 Datetrue
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
HIBCCD090800025750 [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 Date2024-01-31
Device Publish Date2024-01-23

On-Brand Devices [DEXIS Ti2 Sensor Kit]

D090800025840Upgrade Kit, Platinum to Ti2
D090800025800DEXIS Ti2 Warranty Replacement - R
D090800025790Upgrade Kit, Sensor to Ti2
D090800025780DEXIS Ti2 Warranty Replacement NEW
D090800025750DEXIS Ti2 Kit, EN FR-CA

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