CONSEAL 7850016

GUDID DO3678500161

SDI LIMITED

Dental pit/fissure sealant
Primary Device IDDO3678500161
NIH Device Record Key696b613b-fc2b-4979-8f45-b2fd93ce75b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCONSEAL
Version Model NumberCONSEAL CLEAR 4 SYR KT
Catalog Number7850016
Company DUNS753221852
Company NameSDI LIMITED
Device Count4
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18002285166
Emailinfo@sdi.com.au

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCDO3678500160 [Unit of Use]
HIBCCDO3678500161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBCSEALANT, PIT AND FISSURE, AND CONDITIONER

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-27

On-Brand Devices [CONSEAL]

DO3678500161CONSEAL CLEAR 4 SYR KT
DO3678500131CONSEAL F SYR BULK KT
DO3678500121CONSEAL F SYR KT
DO3678500081CONSEAL F KT
DO3678500061CONSEAL F 5ML

Trademark Results [CONSEAL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CONSEAL
CONSEAL
88957911 not registered Live/Pending
Medtech Products Inc.
2020-06-10
CONSEAL
CONSEAL
87578743 not registered Dead/Abandoned
Henry Chung
2017-08-22
CONSEAL
CONSEAL
87516381 not registered Live/Pending
ConSeal International Incorporated
2017-07-05
CONSEAL
CONSEAL
79009622 3177207 Dead/Cancelled
Coloplast A/S
2005-02-21
CONSEAL
CONSEAL
78157146 not registered Dead/Abandoned
KRAUS, JON G.
2002-08-23
CONSEAL
CONSEAL
77472868 not registered Dead/Abandoned
The Sherwin-Williams Company
2008-05-13
CONSEAL
CONSEAL
77116075 not registered Dead/Abandoned
Advanced Neuromodulation Systems, Inc.
2007-02-26
CONSEAL
CONSEAL
77012510 3371348 Live/Registered
ConSeal International Incorporated
2006-10-03
CONSEAL
CONSEAL
76661566 3433690 Live/Registered
Conseal International Incorporated
2006-06-14
CONSEAL
CONSEAL
76484360 2862145 Dead/Cancelled
VISUAL PHYSICS, LLC
2003-01-22
CONSEAL
CONSEAL
75923146 not registered Dead/Abandoned
HIGHLAND VETPHARMA, LLC
2000-02-18
CONSEAL
CONSEAL
75922237 not registered Dead/Abandoned
HIGHLAND VETPHARMA, LLC
2000-02-18

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