KaVo OP 3D Vision

GUDID EKAV083082000

V10

Imaging Sciences International

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Primary Device IDEKAV083082000
NIH Device Record Key8589a4ca-d3e2-473e-b76b-6091eabbe241
Commercial Distribution StatusIn Commercial Distribution
Brand NameKaVo OP 3D Vision
Version Model Number0.830.8200
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
HIBCCEKAV083082000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OASX-Ray, Tomography, Computed, Dental

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 OP 3D Vision]

EKAV083083000V17
EKAV083082000V10
EKAV083081000V8
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