Genius Variable Operating System 4056

GUDID 00883205101648

Genius 8:1 Contra-Angle Kit

ULTRADENT PRODUCTS, INC.

Dental laboratory drilling system motor
Primary Device ID00883205101648
NIH Device Record Key6389de13-2c13-4a86-9d4f-8b72c4a080e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenius Variable Operating System
Version Model Number4056
Catalog Number4056
Company DUNS013369913
Company NameULTRADENT PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(801)572-4200
Emailcustomerservice@ultradent.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100883205101648 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBWController, foot, handpiece and cord

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00883205101648]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-02-07

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