Primary Device ID | EDEL6021160 |
NIH Device Record Key | a7e77076-4932-4788-b5e4-9a3396b2b6ba |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Insure® Silanator |
Version Model Number | 602116 |
Catalog Number | 602116 |
Company DUNS | 344805101 |
Company Name | DeltaMed GmbH |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D7796021160 [Previous] |
HIBCC | EDEL6021160 [Primary] |
KLE | Agent, Tooth Bonding, Resin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-20 |
Device Publish Date | 2023-06-12 |
EDEL16110100 - 3Delta Etemp | 2023-09-25 3Delta Etemp A1, 1000g |
EDEL16110200 - 3Delta Etemp | 2023-09-25 3Delta Etemp A2, 1000g |
EDEL16110300 - 3Delta Etemp | 2023-09-25 3Delta Etemp A3, 1000g |
EDEL3011OP0 - Renamel® Flowable Microfill | 2023-09-22 Renamel® Flowable Microfill OPAL™, Syringe 3g |
EDEL6071OP0 - Renamel® Microfill | 2023-09-22 Renamel® Microfill OPALITE™, Syringe 4g |
EDEL13700100 - DELTASPLINT | 2023-07-07 DELTASPLINT, 12 Rods |
EDEL13700200 - DELTABOND | 2023-07-07 DELTABOND, Bottle 10ml |
EDEL13700300 - DELTAGLACE | 2023-07-07 DELTAGLACE, Bottle 10ml |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INSURE 98041149 not registered Live/Pending |
Curtiss-Wright Flow Control Corporation 2023-06-13 |
INSURE 86901380 5044834 Live/Registered |
Enterix, Inc. 2016-02-08 |
INSURE 78232524 2909232 Dead/Cancelled |
Enterix Inc. 2003-04-01 |
INSURE 78232512 2978654 Live/Registered |
Enterix Inc. 2003-04-01 |
INSURE 78165733 2732347 Live/Registered |
Brandt Consolidated, Inc. 2002-09-19 |
INSURE 77920655 not registered Dead/Abandoned |
WARBINGTON, TIMOTHY 2010-01-26 |
INSURE 77726007 4364957 Live/Registered |
Geovada LLC 2009-04-30 |
INSURE 77118666 not registered Dead/Abandoned |
W.C. Bradley Company 2007-02-28 |
INSURE 77118438 not registered Indifferent |
W.C. Bradley Company 0000-00-00 |
INSURE 76533458 not registered Dead/Abandoned |
Botanical Laboratories, Inc. 2003-07-30 |
INSURE 76494198 not registered Dead/Abandoned |
Mannington Carpets, Inc. 2003-03-03 |
INSURE 76024894 2675417 Dead/Cancelled |
SCHWAN'S IP, LLC 2000-04-13 |