Opal Seal 500095

GUDID 00883205015686

Metal Opal Seal Tips 100 Pack

ULTRADENT PRODUCTS, INC.

Syringe tip cap
Primary Device ID00883205015686
NIH Device Record Key55dd1f84-5593-46f5-92ed-335cedff296f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOpal Seal
Version Model Number500095
Catalog Number500095
Company DUNS013369913
Company NameULTRADENT PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS100883205015686 [Primary]

FDA Product Code

EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-05-29
Device Publish Date2018-04-28

On-Brand Devices [Opal Seal]

00883205103284Opal Seal Trial Syringe
00883205103277Opal Seal Refill
00883205103260Opal Seal Kit
00883205103253Opal Seal Intro Kit
00883205103239Opal Seal Adhesives Trial Kit
00883205015709Metal Opal Seal Tips 500pk
00883205015686Metal Opal Seal Tips 100 Pack
00883205015679Metal Opal Seal Tips 20 Pack
00883205015488Opal Seal Tips 20 Pack
00883205015266Opal Seal Tips 100 Pack
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