Lumaloc 500088-

GUDID 00883205015624

Lumaloc Kit 2pk

ULTRADENT PRODUCTS, INC.

Silicone dental impression material
Primary Device ID00883205015624
NIH Device Record Key8b877a9f-6f1d-4c65-be67-e2c75753c1ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameLumaloc
Version Model Number500088-
Catalog Number500088-
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 Datetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 18 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100883205015624 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMATERIAL, IMPRESSION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-01
Device Publish Date2018-08-31

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