KaVo IXS Size 1 Sensor Kit

GUDID EKAV101461040

Imaging Sciences International

Dental digital imaging sensor, intraoral
Primary Device IDEKAV101461040
NIH Device Record Keye8699024-bee9-48e6-8f7a-d1b818baff35
Commercial Distribution StatusIn Commercial Distribution
Brand NameKaVo IXS Size 1 Sensor Kit
Version Model Number1.014.6104
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
HIBCCEKAV101461040 [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 1 Sensor Kit]

EKAV1014610401.014.6104
EKAV1013971801.013.9718
EKAV1013971701.013.9717
EKAV1013971601.013.9716

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