DEXIS Titanium Warranty Replacement

GUDID EKAV101329490

Imaging Sciences International

Dental digital imaging sensor, intraoral
Primary Device IDEKAV101329490
NIH Device Record Keydcb10bb2-f07b-4fc2-9385-5e77e54a3d29
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEXIS Titanium Warranty Replacement
Version Model Number1.013.2949
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
HIBCCEKAV101329490 [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

Devices Manufactured by Imaging Sciences International

EKAV083081000 - KaVo OP 3D Vision2022-01-31 V8
EKAV083082000 - KaVo OP 3D Vision2022-01-31 V10
EKAV083083000 - KaVo OP 3D Vision2022-01-31 V17
EKAV085006210 - NOMAD Pro2 Packaged X-Ray System - R2022-01-31
EKAV085006220 - NOMAD Pro2 Packaged X-Ray System Black-R2022-01-31
EKAV101261800 - DEXIS Titanium Intraoral X-Ray Sensor2022-01-31
EKAV101261810 - KaVo IXS Size 1, Intra-Oral X-Ray Sensor2022-01-31
EKAV101261820 - KaVo IXS Size 2, Intra-Oral X-Ray Sensor2022-01-31

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