VistaScan Ultra View

GUDID D67821701100011

The unit is intended exclusively for use in dental applications for the scanning and processing of image data on an image plate.

AIR TECHNIQUES, INC.

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Primary Device IDD67821701100011
NIH Device Record Key2d6a8207-7ef1-495e-badf-5cdf0285bb6b
Commercial Distribution StatusIn Commercial Distribution
Brand NameVistaScan Ultra View
Version Model Number2170100500
Company DUNS043835081
Company NameAIR TECHNIQUES, INC.
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

Customer Support Contacts

Phone+1 (516) 214-5512
Emailmardonio.nicolas@airtechniques.com
Phone+1 (516) 214-5512
Emailmardonio.nicolas@airtechniques.com
Phone+1 (516) 214-5512
Emailmardonio.nicolas@airtechniques.com
Phone+1 (516) 214-5512
Emailmardonio.nicolas@airtechniques.com
Phone+1 (516) 214-5512
Emailmardonio.nicolas@airtechniques.com
Phone+1 (516) 214-5512
Emailmardonio.nicolas@airtechniques.com
Phone+1 (516) 214-5512
Emailmardonio.nicolas@airtechniques.com
Phone+1 (516) 214-5512
Emailmardonio.nicolas@airtechniques.com
Phone+1 (516) 214-5512
Emailmardonio.nicolas@airtechniques.com
Phone+1 (516) 214-5512
Emailmardonio.nicolas@airtechniques.com
Phone+1 (516) 214-5512
Emailmardonio.nicolas@airtechniques.com
Phone+1 (516) 214-5512
Emailmardonio.nicolas@airtechniques.com
Phone+1 (516) 214-5512
Emailmardonio.nicolas@airtechniques.com
Phone+1 (516) 214-5512
Emailmardonio.nicolas@airtechniques.com
Phone+1 (516) 214-5512
Emailmardonio.nicolas@airtechniques.com
Phone+1 (516) 214-5512
Emailmardonio.nicolas@airtechniques.com
Phone+1 (516) 214-5512
Emailmardonio.nicolas@airtechniques.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD67821701005000 [Primary]
HIBCCD67821701100011 [Package]
Contains: D67821701005000
Package: Box [1 Units]
In Commercial Distribution

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 Date2023-05-01
Device Publish Date2023-04-21

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