KaVo IXS Size 1 Sensor Kit

GUDID D090101397160

Dental Imaging Technologies Corporation

Dental digital imaging sensor, intraoral
Primary Device IDD090101397160
NIH Device Record Key761e9727-c725-421f-aa41-99eae22a4de6
Commercial Distribution StatusIn Commercial Distribution
Brand NameKaVo IXS Size 1 Sensor Kit
Version Model Number1.013.9716
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 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
HIBCCD090101397160 [Primary]
HIBCCEKAV101397160 [Previous]

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 Date2022-03-14
Device Publish Date2022-03-04

On-Brand Devices [KaVo IXS Size 1 Sensor Kit]

D0901014610401.014.6104
D0901013971801.013.9718
D0901013971701.013.9717
D0901013971601.013.9716

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