KaVo IXS Size 2 Sensor Kit

GUDID EKAV101397210

Imaging Sciences International

Dental digital imaging sensor, intraoral
Primary Device IDEKAV101397210
NIH Device Record Keyb62d1c33-389f-43da-a0e6-3653c52444a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameKaVo IXS Size 2 Sensor Kit
Version Model Number1.013.9721
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
HIBCCEKAV101397210 [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 [KaVo IXS Size 2 Sensor Kit]

EKAV1014610501.014.6105
EKAV1013972101.013.9721
EKAV1013972001.013.9720
EKAV1013291501.013.2915

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