NOMAD Pro2 Packaged X-Ray System Black-R

GUDID D090085006220

Dental Imaging Technologies Corporation

Diagnostic x-ray system generator, hand-held
Primary Device IDD090085006220
NIH Device Record Key0ed861b2-fc0a-4664-a8fa-3b98b940aee0
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOMAD Pro2 Packaged X-Ray System Black-R
Version Model Number0.850.0622
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
HIBCCD090085006220 [Primary]
HIBCCEKAV085006220 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EHDUnit, X-Ray, Extraoral With Timer

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

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